1,045 Financial Regulations jobs in the United States

Our client is actively seeking a highly experienced and diligent Lead Compliance Officer to ensure adherence to all relevant financial regulations and corporate policies. This critical role is essential for maintaining the integrity and trustworthiness of our operations. As the Lead Compliance Officer, you will be responsible for developing, implementing, and overseeing comprehensive compliance programs. You will lead a team of compliance professionals, providing guidance, training, and strategic direction to foster a culture of compliance throughout the organization. This position requires a meticulous approach, a strong understanding of financial laws, and exceptional leadership qualities.

Responsibilities:

• Develop, implement, and maintain robust compliance programs, policies, and procedures in alignment with federal and state financial regulations.
• Conduct regular risk assessments to identify potential areas of compliance vulnerability and implement corrective actions.
• Oversee internal audits and investigations, ensuring thorough documentation and timely resolution of issues.
• Interpret complex regulatory requirements and provide clear guidance to business units.
• Lead and mentor a team of compliance analysts and specialists, fostering their professional development.
• Develop and deliver comprehensive compliance training to employees at all levels.
• Serve as the primary point of contact for regulatory agencies during examinations and inquiries.
• Monitor changes in the regulatory landscape and proactively adapt compliance strategies.
• Report on compliance status and risk assessment findings to senior management and the board of directors.
• Ensure the company's compliance with anti-money laundering (AML) and know your customer (KYC) regulations.

Qualifications:

• Juris Doctor (JD) degree or a Master's degree in Law, Finance, Business Administration, or a related field.
• At least 10 years of progressive experience in corporate compliance, regulatory affairs, or legal roles within the financial services industry.
• In-depth knowledge of financial regulations (e.g., SEC, FINRA, Dodd-Frank, BSA/AML).
• Proven experience in developing and implementing compliance programs.
• Strong leadership and team management skills, with a track record of building and motivating high-performing teams.
• Excellent analytical, problem-solving, and decision-making abilities.
• Exceptional written and verbal communication skills, with the ability to explain complex regulatory concepts clearly.
• High ethical standards and integrity.
• Ability to work effectively under pressure and manage multiple priorities.
• Relevant certifications such as CCEP, CRCM, or CAMS are a plus.

This is an on-site position located in San Antonio, Texas, US . Successful candidates must be able to work from our office location.

Our client, a prominent financial institution in Omaha, Nebraska, US , is seeking a highly experienced and dedicated Senior Compliance Officer to ensure adherence to all applicable financial regulations and internal policies. This crucial role involves developing, implementing, and overseeing the company's compliance programs. You will be responsible for risk assessment, regulatory interpretation, policy development, and training initiatives to maintain the highest standards of integrity and ethical conduct. The ideal candidate will possess a deep understanding of banking and finance laws, a sharp analytical mind, and exceptional communication skills.

Responsibilities:

• Develop, implement, and maintain robust compliance programs, policies, and procedures aligned with federal and state banking regulations.
• Monitor regulatory changes and assess their impact on the organization, ensuring timely updates and implementation.
• Conduct regular compliance risk assessments and audits to identify potential areas of non-compliance.
• Investigate compliance issues and violations, recommending and implementing corrective actions.
• Develop and deliver compliance training programs to employees at all levels.
• Serve as a primary point of contact for regulatory agencies during examinations and inquiries.
• Review marketing materials, product offerings, and operational processes for compliance.
• Advise business units on compliance matters, providing guidance and support.
• Maintain accurate and up-to-date compliance records and documentation.
• Stay abreast of industry best practices and emerging compliance trends.
• Manage relationships with external legal counsel and compliance consultants as needed.
• Ensure the company operates with the highest ethical standards and integrity.

Qualifications:

• Bachelor's degree in Law, Finance, Business Administration, or a related field. Advanced degree (JD, MBA) or relevant professional certifications (e.g., CRCM, CCEP) highly preferred.
• 7+ years of experience in compliance, risk management, or internal audit within the financial services industry.
• In-depth knowledge of banking regulations such as BSA/AML, KYC, UDAAP, and relevant consumer protection laws.
• Proven ability to interpret complex regulations and apply them to business operations.
• Strong analytical, problem-solving, and critical thinking skills.
• Excellent written and verbal communication skills, with the ability to present complex information clearly.
• Experience in developing and delivering compliance training.
• Ability to manage multiple priorities and work effectively under pressure.
• High level of integrity and professionalism.
• Experience with regulatory reporting and examinations is essential.

This is an excellent opportunity to contribute to the stability and integrity of a leading financial institution. Our client offers a competitive salary, attractive benefits package, and a supportive environment for professional growth. Join a team dedicated to upholding the highest compliance standards in the industry.

Our client, a prominent financial institution, is seeking a highly diligent and experienced Senior Compliance Officer to strengthen their regulatory compliance team. This vital role will be based at our offices in Indianapolis, Indiana, US , and will focus on ensuring adherence to complex financial regulations and internal policies. You will be responsible for developing, implementing, and managing compliance programs, conducting risk assessments, and performing internal audits to identify and mitigate potential compliance issues. The ideal candidate will possess a comprehensive understanding of banking regulations, anti-money laundering (AML) laws, know-your-customer (KYC) procedures, and other relevant financial compliance frameworks. You will work closely with various departments, including operations, legal, and risk management, to provide guidance on compliance matters and promote a culture of integrity throughout the organization. This position requires exceptional analytical skills, meticulous attention to detail, and strong communication abilities to effectively interpret and convey complex regulatory requirements. You will also be involved in training employees on compliance best practices and staying updated on evolving regulatory landscapes. This is a crucial role in safeguarding the company's reputation and ensuring operational integrity.
Responsibilities:

• Develop, implement, and maintain robust compliance programs and policies.
• Conduct regular risk assessments and internal audits to ensure adherence to financial regulations.
• Monitor regulatory changes and update compliance procedures accordingly.
• Investigate potential compliance breaches and recommend corrective actions.
• Provide guidance and training to employees on compliance requirements and best practices.
• Prepare compliance reports for senior management and regulatory bodies.
• Liaise with internal and external auditors and examiners.
• Ensure compliance with AML, KYC, and other relevant financial crime prevention regulations.
• Promote a strong culture of compliance and ethical conduct throughout the organization.

Qualifications:

• Bachelor's degree in Finance, Law, Business Administration, or a related field.
• Minimum of 7 years of experience in financial services compliance or regulatory affairs.
• In-depth knowledge of banking regulations, AML, KYC, and other relevant compliance frameworks.
• Proven experience in conducting compliance risk assessments and internal audits.
• Excellent analytical, problem-solving, and critical thinking skills.
• Strong understanding of regulatory reporting requirements.
• Exceptional written and verbal communication skills.
• Relevant professional certifications (e.g., CAMS, CRCM) are a plus.

The Center for Elders’ Independence is a PACE (Program of All-Inclusive Care for the elderly) organization (PO) that uses an interdisciplinary team approach for care planning and implementing purposeful high quality, affordable, and integrated health care services to the elderly. Our elderly meet PACE requirements as prescribed by CMS and are referred to as participants. Our PO includes Adult Day Health Centers and primary care clinics, promoting participant autonomy, quality of life and the ability for individuals to live in their communities

THE POS I TION : The Director of Regulatory Affairs will develop and execute healthcare policy analysis and s trategic oversight of CEI’s regulatory strategy to ensure compliance with federal and California PACE requirements ( Centers for Medicare & Medicaid Services (CMS) and California Department of Health Care Services (DHCS) ). This D irector provides strategic guidance, supports compliance program management, and serves as the primary liaison with government agencies, particularly CMS and DHCS . This leader will manage regulatory submissions, guide cross ‑ functional teams through complex healthcare policy and regulatory matters, and support audits, inspections, and ongoing regulatory reporting. The role requires deep experience with healthcare policy , PACE federal and state regulatory frameworks, strong project and stakeholder management skills, and proven leadership in healthcare regulatory/compliance environments .

DUTIES AND RESPONSIBILITIES:

• Regulatory Affairs : Develop and implement regulatory strategies that support CEI’s PACE program growth and ongoing compliance with CMS and DHCS requirements. Act as the primary point of contact for CMS and state agencies , which involves managing relationships, responding to inquiries, and representing the PACE organization during audits or investigations . Lead preparation, submission, tracking, and maintenance of PACE applications, amendments, notices, and other regulatory filings to CMS and DHCS. Partner with legal counsel, external compliance consultants, and the Compliance Officer to coordinate filings, audits, and regulatory responses.
• Policy I nterpretation and S trategy: Monitor, interpret and communicate new federal and state regulations, policy changes, and guidance documents to determine their impact on PACE operations. Assess operational impact and develop and communicate a regulatory strategy to senior leadership to implement required changes.

• Compliance P rogram M anagement : Implement and m onitor effective compliance program elements . C reat e policies and procedures, ensur e annual risk assessments are performed, and manag e an annual auditing plan s .

• Risk A ssessment and M itigation: Identify and assess potential compliance risks and develop strategies to mitigate them. This includes resolving any instances of non-compliance and implementing corrective action plans. Conduct regulatory risk assessments; identify, escalate, and mitigate regulatory risks in collaboration with the General Counsel, Compliance Officer, and operational leaders. Review marketing and promotional materials for regulatory compliance. Oversee annual compliance reviews, audits, testing, and monitoring of internal controls related to PACE operations and regulatory filings.

• Process Improvement: Design, enhance, and maintain compliance workflows, systems, and internal controls to support efficient regulatory operations . Represent CEI on multidisciplinary continuous improvement projects and ensure regulatory perspectives are integrated into organizational strategy

• Training and E ducation: Draft, update, and maintain policies, procedures, and guidance documents; provide regulatory education across departments. Create and deliver training programs to ensure all staff and contractors understand and comply with regulatory requirements. This fosters a culture of compliance throughout the organization.

QUALIFICATIONS : Deep, working knowledge of healthcare policy, PACE federal and state regulatory frameworks, including CMS and DHCS requirements.

• 15+ years of progressive experience in healthcare policy analysis, regulatory affairs, compliance, and PACE operations — including direct experience working with or responding to CMS and/or DHCS.
• Master’s degree in Healthcare Administration, Regulatory Affairs, Public Health, Juris Doctorate, or a related field (or equivalent experience).
• Proven ability to lead cross-functional teams and manage enterprise-level regulatory programs.
• Training leader, facilitator and mentor on Kaizen, A3 and data collection processes.
• Strong written and verbal

The above job description is intended to communicate the general function of the mentioned position and by no means shall be considered an exhaustive or complete outline of the specific tasks and functions that will be required. CEI reserves the right to change job descriptions, site assignments, and or work hours as required by the needs of the program. All employees are expected to perform their duties within their ability as required by the job and/or as requested by management.

Center for Elders’ Independence is a PACE (Program of All- Inclusive Care for the Elderly) organization that uses an interdisciplinary team approach to care planning and care implementation for the purpose of providing high quality, affordable, integrated health care services to the elderly, including an Adult Day Health Center, and promoting autonomy, quality of life and the ability of individuals to live in their communities. Unlike other healthcare plans, CEI is not a "fee-for-service" plan. It is a “capitation” healthcare plan. CEI is paid a set amount for each person enrolled in our program, whether or not that individual seeks care. We are a growing company that offers stability and continues to thrive.

Sumitomo Pharma Co., Ltd. is a global pharmaceutical company based in Japan with key operations in the U.S. (Sumitomo Pharma America, Inc.), Canada (Sumitomo Pharma Canada, Inc.) and Europe (Sumitomo Pharma Switzerland GmbH) focused on addressing patient needs in oncology, urology, women's health, rare diseases, psychiatry & neurology, and cell & gene therapies. With several marketed products in the U.S., Canada, and Europe, and a diverse pipeline of early- to late-stage assets, we aim to accelerate discovery, research, and development to bring novel therapies to patients sooner. For more information on SMPA, visit our website ( or follow us on LinkedIn ( .
**Job Overview**
We are currently seeking a dynamic, highly motivated, and experienced individual for the position of **Director Regulatory Affairs** . The Director is part of the Global Regulatory Affairs (GRA) team based in the US. He/she will primarily function as the Regional Regulatory Leader (RRL) and/or Global Regulatory Leader (GRL) for assigned projects. This position is expected to lead the development and implementation of regulatory strategy from proof of concept, development, registration, and post-approval for projects within the portfolio of the company. This position may train/mentor junior staff.
This position works with a high level of autonomy and requires limited coaching and mentoring.
**Job Duties and Responsibilities**
Manage and Develop Talent
+ May train/mentor junior staff
Phases I-IV Research & Development Activities
+ As a Regional Regulatory Lead, manage regional (United States and/or European) regulatory activities as part of a Global Regulatory Team (GRT)
+ As a part of the Global Regulatory Team (GRT), leads regulatory activities for assigned project(s) in line with the global registration strategy of the product
+ Competently represents GRA on project team meetings
+ Leads and coordinates project team members in developing strategy for applicable documents/ activities.
+ Plans, coordinates, authors, and prepares regulatory submissions and works closely with Regulatory Operations in the electronic submission
+ Assesses and communicates regulatory requirements ensuring activities are in compliance with applicable regulations and guidelines
+ Leads documentation of regulatory authority interactions including decisions and outcomes
+ Provides updates at the Global Regulatory Team meetings and project teams as needed
+ Collaborates effectively with regulatory operations leader (ROL)
+ Maintains professional working relationship with colleagues, fostering collaboration, and idea sharing
+ Reviews nonclinical, clinical and CMC documentation (e.g. nonclinical study reports, clinical protocols/study reports, investigator brochures, CMC information/data) and contributes to content as needed
+ Advises team members of major regulatory issues and provides possible solutions and leads the mitigation strategy
+ Leads and coordinates local project team members in developing strategy for applicable documents/activities
+ Ensures the quality and content of all submissions to Health Authorities
+ Leads the regional health authority meetings, liaison with local Health Authority,
+ Document owner of briefing book documentation to Health Authorities
+ Assist with development of the global regulatory functional plan through research, review and interpretation of related product approvals, current regulatory guidance documents and recent public Advisory Committee proceedings to support the successful submission and achievement of target product labeling
+ Accountable in conjunction with the GRL for developing and maintaining the development core data sheet (DCDS) if required
+ Ensure compliance with global regulatory requirements and adherence to regulatory internal policies and processes and coordinate regulatory compliance activities at a global level
+ Provide strategic review of dossier summaries, expert statements, and development management plans
+ Provide updates to the GRT, project teams, and governance boards as needed
+ Leads Global Regulatory Team (GRT), oversees planning and execution of global regulatory activities and submissions
+ May be responsible for creating and reviewing SOPs and regulatory department operating procedures.
Key Core Competencies
+ Strong verbal and written communication skills; interpersonal skills; listening skills; and organizational skills required
+ Unquestionable ethics, professional integrity, and personal values consistent with the SMPA values
+ Ability to work in a diverse environment
+ Demonstrated ability to adapt to changing priorities and work effectively in a matrix organization
+ Demonstrated ability to facilitate appropriate team decisions
+ Sense of urgency and perseverance to achieve results
+ Experience contributing to electronic regulatory submissions and working with regulatory templates
+ Advanced understanding of medical terminology, and FDA and ICH regulations/guidances specific to clinical research and general product development in the pharmaceutical industry
+ Experience reviewing nonclinical, clinical and CMC documentation (e.g. nonclinical study reports, clinical protocols/study reports, investigator brochures, CMC information/data) and contribute to content as needed
+ Understands issues, problems and opportunities by comparing data from different sources to draw conclusions and then can choose a course of action or develop the appropriate solution
+ Proven success/major involvement in NDA/MAA/CTD submissions and approval
+ Capable of effectively negotiating with others while maintaining composure
+ Development and preparation of successful regulatory strategies and the ability to contribute to the development and writing of a regulatory strategy document
+ Ability to learn new therapeutic areas when necessary
+ Prior history with post-marketing/brand optimization strategies and commercial awareness
+ Experience interacting with the FDA and ex-US Health Authorities
+ Experience in successfully leading teams and providing leadership in Health Authority negotiations and meetings
+ Ability to make complex decisions and willingness to defend difficult positions.
+ Comfortable presenting to all levels of the organization including Senior Management.
+ High degree of organizational awareness, ability to connect the dots to understand all the interdependency and big picture
**Education and Experience**
+ Bachelor's degree in a related field required.
+ 8 - 12 years with Master's of relevant experience in biotech or pharmaceutical industry with minimum of 8 years focused in regulatory affairs.
+ Master's degree required (preferably in a scientific discipline)
The base salary range for this role is $187,520 to $234,400. Base salary is part of our total rewards package which also includes the opportunity for merit-based salary increases, short incentive plan participation, eligibility for our 401(k) plan, medical, dental, vision, life and disability insurances and leaves provided in line with your work state. Our robust time-off policy includes flexible paid time off, 11 paid holidays plus additional time off for a shut-down period during the last week of December, 80 hours of paid sick time upon hire and each year thereafter. Total compensation, including base salary to be offered, will depend on elements unique to each candidate, including candidate experience, skills, education and other factors permitted by law.
Disclaimer: The above statements are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel so classified. All personnel may be required to perform duties outside of their normal responsibilities from time to time, as needed.
**Confidential Data** : All information (written, verbal, electronic, etc.) that an employee encounters is considered confidential.
**Compliance** : Achieve and maintain Compliance with all applicable regulatory, legal and operational rules and procedures, by ensuring that all plans and activities for and on behalf of Sumitomo Pharma America (SMPA) and affiliates are carried out with the "best" industry practices and the highest ethical standards.
It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.
**Mental/Physical Requirements** : Fast paced environment handling multiple demands. Must be able to exercise appropriate judgment as necessary. Requires a high level of initiative and independence. Excellent written and oral communication skills required. Requires ability to use a personal computer for extended periods of time.
**Sumitomo Pharma America (SMPA)** **is an Equal Employment Opportunity (EEO) employer**
Qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.
Sumitomo Pharma Co., Ltd., is a global pharmaceutical company based in Japan with operations in the U.S. (Sumitomo Pharma America, Inc.), focused on addressing patient needs in oncology, urology, women's health, rare diseases, cell & gene therapies and CNS. With several marketed products and a diverse pipeline of early- to late-stage investigational assets, we aim to accelerate discovery, research, and development to bring novel therapies to patients sooner. For more information on SMPA, visit our website or follow us on LinkedIn.
Sumitomo Pharma America (SMPA) endeavors to make its application process accessible to all. If you would like to contact us regarding the accessibility of our website or need assistance completing the application process, please contact SMPA at
This contact information is for accommodation requests only and cannot be used to inquire about the status of applications.
At Sumitomo Pharma America, our work is guided by the Sumitomo Pharma mission, vision and values, which tie closely to our company's cultural pillars.
**Our** **Mission**
_To broadly contribute to society through value creation based on innovative research and development activities for the betterment of healthcare and fuller lives of people_ _worldwide_
**Our** **Vision**
_For Longer and Healthier Lives, we unlock the future with cutting edge technology and_ _ideas_

The **Director, Regulatory Affairs** is a key strategist, responsible for developing and executing the global regulatory strategy for **Stryker Sustainability Solutions (SSS)** business unit focused on providing reprocessing and remanufacturing solutions to our customers globally. The Director will partner closely with business unit leadership and respective Marketing, R&D, Clinical and Quality teams, and will lead a team of 5 direct reports.
This leader is required to be based in **Tempe, AZ** with a hybrid work schedule of three days per week in office. Relocation support can be provided.
**Key Areas of Responsibility:**
+ Develops the organization's national, regional, and global regulatory position(s) and strategy based upon assessment and synthesis of internal and external intelligence
+ Recognized as thought leader in advocacy activities
+ Develops product positioning strategies for complex and/or critical products based upon current regulatory requirements and planned regulatory changes
+ Accesses and interprets environmental scans and other socioeconomic, scientific, and regulatory intelligence to better understand and contribute product positioning, competition, opportunities, and to drive regulatory strategy
+ Integrates regulatory considerations into the organization's global product entry and exit strategy
+ Identifies issues early in the development or research phase that could impact regulatory strategy, submissions and/or product launches for complex and/or critical products
+ Manages negotiations with regulatory authorities on complex issues throughout the product lifecycle
+ Influences changing regulations and guidance
+ Interfaces and establishes working relationships with multiple government and non-government organizations impacting market access and distribution
+ Leads efforts to incorporate regulatory strategies to expedite development for products intended for serious or life-threatening medical conditions or that address unmet medical needs
+ Leads negotiations with regulatory and other health authorities on complex issues throughout the product lifecycle
+ Leads the development and execution of good regulatory practices and policy
+ Provides strategic input on regulatory requirements to R&D and clinical leads for complex and/or critical products
+ Leads the regulatory team's engagement in evaluation of risk and safety issues for complex and/or critical products and recommends regulatory solutions during preapproval/clinical phases
+ Participates in risk-based decisions on compassionate use/special access approvals based upon patient needs and risk assessment
+ Approves regulatory filing strategies for complex and/or critical products based upon proposed preclinical, clinical, and manufacturing changes
+ Reviews and approves publicly disseminated information on product submission approval status
+ Review regulatory compliance requirements for changes affecting product submission and device manufacturing in global markets
+ Implement regulatory system changes to support evolving regulations and international standards
+ Provide a strategic direction and tactical focus to the Regulatory Affairs organization and influence the direction of divisional RA activities
+ Ensure that pre-market submissions, product registrations, and related functions are conducted in compliance with international standards and government regulations in support of company mission
+ Establish standard process to ensure appropriate resolution and management of the responsible task owner
+ Chair meetings required to drive closure of regulatory issues
+ Manage and provide updates for regulatory metrics. Implement appropriate enhancements
+ Represent regulatory processes during internal and external audits
+ Define targets, KPIs, performance objectives, etc. for individuals within functional role, and manage direct reports to meet or exceed these targets
+ Recruit, select, and on-board top talent
+ Develop talent within team to increase performance. Actively address performance issues on team
+ Maintain a high level of team engagement
+ Participate in advocacy activities of a more advanced strategic nature
**Education / Work Experience:**
+ BS in Engineering or other relevant field of study
+ Minimum of 10 years' experience
+ Master's Degree or equivalent preferred
+ RAC desired
**Knowledge / Competencies:**
+ Demonstrated knowledge and application of regulatory requirements, including ISO, FDA, and International requirements
+ Demonstrated expertise in regulatory systems in a regulated environment
+ Demonstrated project management skills
+ Demonstrated verbal, written, and interpersonal communication skills
+ Demonstrated ability to work in a team environment, interact effectively with management from other functions
+ Demonstrated ability to manage a multi-discipline, multi-technology, team-based organization and assume responsibility of quality, regulatory, and compliance targets
+ Demonstrated ability to initiate work
+ Demonstrated analytical ability
+ Demonstrated ability to make effective decisions
+ Experience with recruiting, people development
+ Influence across the organization
Health benefits include: Medical and prescription drug insurance, dental insurance, vision insurance, critical illness insurance, accident insurance, hospital indemnity insurance, personalized healthcare support, wellbeing program and tobacco cessation program. Financial benefits include: Health Savings Account (HSA), Flexible Spending Accounts (FSAs), 401(k) plan, Employee Stock Purchase Plan (ESPP), basic life and AD&D insurance, and short-term disability insurance. Stryker offers innovative products and services in MedSurg, Neurotechnology, Orthopaedics and Spine that help improve patient and healthcare outcomes. Alongside its customers around the world, Stryker impacts more than 150 million patients annually. Depending on customer requirements employees and new hires in sales and field roles that require access to customer accounts as a function of the job may be required to obtain various vaccinations as an essential function of their role.
Stryker Corporation is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, or protected veteran status. Stryker is an EO employer - M/F/Veteran/Disability.

Sumitomo Pharma Co., Ltd. is a global pharmaceutical company based in Japan with key operations in the U.S. (Sumitomo Pharma America, Inc.), Canada (Sumitomo Pharma Canada, Inc.) and Europe (Sumitomo Pharma Switzerland GmbH) focused on addressing patient needs in oncology, urology, women's health, rare diseases, psychiatry & neurology, and cell & gene therapies. With several marketed products in the U.S., Canada, and Europe, and a diverse pipeline of early- to late-stage assets, we aim to accelerate discovery, research, and development to bring novel therapies to patients sooner. For more information on SMPA, visit our website ( or follow us on LinkedIn ( .
**Job Overview**
We are currently seeking a dynamic, highly motivated, and experienced individual for the position of **Director Regulatory Affairs** . The Director is part of the Global Regulatory Affairs (GRA) team based in the US. He/she will primarily function as the Regional Regulatory Leader (RRL) and/or Global Regulatory Leader (GRL) for assigned projects. This position is expected to lead the development and implementation of regulatory strategy from proof of concept, development, registration, and post-approval for projects within the portfolio of the company. This position may train/mentor junior staff.
This position works with a high level of autonomy and requires limited coaching and mentoring.
**Job Duties and Responsibilities**
Manage and Develop Talent
+ May train/mentor junior staff
Phases I-IV Research & Development Activities
+ As a Regional Regulatory Lead, manage regional (United States and/or European) regulatory activities as part of a Global Regulatory Team (GRT)
+ As a part of the Global Regulatory Team (GRT), leads regulatory activities for assigned project(s) in line with the global registration strategy of the product
+ Competently represents GRA on project team meetings
+ Leads and coordinates project team members in developing strategy for applicable documents/ activities.
+ Plans, coordinates, authors, and prepares regulatory submissions and works closely with Regulatory Operations in the electronic submission
+ Assesses and communicates regulatory requirements ensuring activities are in compliance with applicable regulations and guidelines
+ Leads documentation of regulatory authority interactions including decisions and outcomes
+ Provides updates at the Global Regulatory Team meetings and project teams as needed
+ Collaborates effectively with regulatory operations leader (ROL)
+ Maintains professional working relationship with colleagues, fostering collaboration, and idea sharing
+ Reviews nonclinical, clinical and CMC documentation (e.g. nonclinical study reports, clinical protocols/study reports, investigator brochures, CMC information/data) and contributes to content as needed
+ Advises team members of major regulatory issues and provides possible solutions and leads the mitigation strategy
+ Leads and coordinates local project team members in developing strategy for applicable documents/activities
+ Ensures the quality and content of all submissions to Health Authorities
+ Leads the regional health authority meetings, liaison with local Health Authority,
+ Document owner of briefing book documentation to Health Authorities
+ Assist with development of the global regulatory functional plan through research, review and interpretation of related product approvals, current regulatory guidance documents and recent public Advisory Committee proceedings to support the successful submission and achievement of target product labeling
+ Accountable in conjunction with the GRL for developing and maintaining the development core data sheet (DCDS) if required
+ Ensure compliance with global regulatory requirements and adherence to regulatory internal policies and processes and coordinate regulatory compliance activities at a global level
+ Provide strategic review of dossier summaries, expert statements, and development management plans
+ Provide updates to the GRT, project teams, and governance boards as needed
+ Leads Global Regulatory Team (GRT), oversees planning and execution of global regulatory activities and submissions
+ May be responsible for creating and reviewing SOPs and regulatory department operating procedures.
Key Core Competencies
+ Strong verbal and written communication skills; interpersonal skills; listening skills; and organizational skills required
+ Unquestionable ethics, professional integrity, and personal values consistent with the SMPA values
+ Ability to work in a diverse environment
+ Demonstrated ability to adapt to changing priorities and work effectively in a matrix organization
+ Demonstrated ability to facilitate appropriate team decisions
+ Sense of urgency and perseverance to achieve results
+ Experience contributing to electronic regulatory submissions and working with regulatory templates
+ Advanced understanding of medical terminology, and FDA and ICH regulations/guidances specific to clinical research and general product development in the pharmaceutical industry
+ Experience reviewing nonclinical, clinical and CMC documentation (e.g. nonclinical study reports, clinical protocols/study reports, investigator brochures, CMC information/data) and contribute to content as needed
+ Understands issues, problems and opportunities by comparing data from different sources to draw conclusions and then can choose a course of action or develop the appropriate solution
+ Proven success/major involvement in NDA/MAA/CTD submissions and approval
+ Capable of effectively negotiating with others while maintaining composure
+ Development and preparation of successful regulatory strategies and the ability to contribute to the development and writing of a regulatory strategy document
+ Ability to learn new therapeutic areas when necessary
+ Prior history with post-marketing/brand optimization strategies and commercial awareness
+ Experience interacting with the FDA and ex-US Health Authorities
+ Experience in successfully leading teams and providing leadership in Health Authority negotiations and meetings
+ Ability to make complex decisions and willingness to defend difficult positions.
+ Comfortable presenting to all levels of the organization including Senior Management.
+ High degree of organizational awareness, ability to connect the dots to understand all the interdependency and big picture
**Education and Experience**
+ Bachelor's degree in a related field required.
+ 8 - 12 years with Master's of relevant experience in biotech or pharmaceutical industry with minimum of 8 years focused in regulatory affairs.
+ Master's degree required (preferably in a scientific discipline)
The base salary range for this role is $187,520 to $234,400. Base salary is part of our total rewards package which also includes the opportunity for merit-based salary increases, short incentive plan participation, eligibility for our 401(k) plan, medical, dental, vision, life and disability insurances and leaves provided in line with your work state. Our robust time-off policy includes flexible paid time off, 11 paid holidays plus additional time off for a shut-down period during the last week of December, 80 hours of paid sick time upon hire and each year thereafter. Total compensation, including base salary to be offered, will depend on elements unique to each candidate, including candidate experience, skills, education and other factors permitted by law.
Disclaimer: The above statements are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel so classified. All personnel may be required to perform duties outside of their normal responsibilities from time to time, as needed.
**Confidential Data** : All information (written, verbal, electronic, etc.) that an employee encounters is considered confidential.
**Compliance** : Achieve and maintain Compliance with all applicable regulatory, legal and operational rules and procedures, by ensuring that all plans and activities for and on behalf of Sumitomo Pharma America (SMPA) and affiliates are carried out with the "best" industry practices and the highest ethical standards.
It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.
**Mental/Physical Requirements** : Fast paced environment handling multiple demands. Must be able to exercise appropriate judgment as necessary. Requires a high level of initiative and independence. Excellent written and oral communication skills required. Requires ability to use a personal computer for extended periods of time.
**Sumitomo Pharma America (SMPA)** **is an Equal Employment Opportunity (EEO) employer**
Qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.
Sumitomo Pharma Co., Ltd., is a global pharmaceutical company based in Japan with operations in the U.S. (Sumitomo Pharma America, Inc.), focused on addressing patient needs in oncology, urology, women's health, rare diseases, cell & gene therapies and CNS. With several marketed products and a diverse pipeline of early- to late-stage investigational assets, we aim to accelerate discovery, research, and development to bring novel therapies to patients sooner. For more information on SMPA, visit our website or follow us on LinkedIn.
Sumitomo Pharma America (SMPA) endeavors to make its application process accessible to all. If you would like to contact us regarding the accessibility of our website or need assistance completing the application process, please contact SMPA at
This contact information is for accommodation requests only and cannot be used to inquire about the status of applications.
At Sumitomo Pharma America, our work is guided by the Sumitomo Pharma mission, vision and values, which tie closely to our company's cultural pillars.
**Our** **Mission**
_To broadly contribute to society through value creation based on innovative research and development activities for the betterment of healthcare and fuller lives of people_ _worldwide_
**Our** **Vision**
_For Longer and Healthier Lives, we unlock the future with cutting edge technology and_ _ideas_

Sumitomo Pharma Co., Ltd. is a global pharmaceutical company based in Japan with key operations in the U.S. (Sumitomo Pharma America, Inc.), Canada (Sumitomo Pharma Canada, Inc.) and Europe (Sumitomo Pharma Switzerland GmbH) focused on addressing patient needs in oncology, urology, women's health, rare diseases, psychiatry & neurology, and cell & gene therapies. With several marketed products in the U.S., Canada, and Europe, and a diverse pipeline of early- to late-stage assets, we aim to accelerate discovery, research, and development to bring novel therapies to patients sooner. For more information on SMPA, visit our website ( or follow us on LinkedIn ( .
**Job Overview**
We are currently seeking a dynamic, highly motivated, and experienced individual for the position of **Director Regulatory Affairs** . The Director is part of the Global Regulatory Affairs (GRA) team based in the US. He/she will primarily function as the Regional Regulatory Leader (RRL) and/or Global Regulatory Leader (GRL) for assigned projects. This position is expected to lead the development and implementation of regulatory strategy from proof of concept, development, registration, and post-approval for projects within the portfolio of the company. This position may train/mentor junior staff.
This position works with a high level of autonomy and requires limited coaching and mentoring.
**Job Duties and Responsibilities**
Manage and Develop Talent
+ May train/mentor junior staff
Phases I-IV Research & Development Activities
+ As a Regional Regulatory Lead, manage regional (United States and/or European) regulatory activities as part of a Global Regulatory Team (GRT)
+ As a part of the Global Regulatory Team (GRT), leads regulatory activities for assigned project(s) in line with the global registration strategy of the product
+ Competently represents GRA on project team meetings
+ Leads and coordinates project team members in developing strategy for applicable documents/ activities.
+ Plans, coordinates, authors, and prepares regulatory submissions and works closely with Regulatory Operations in the electronic submission
+ Assesses and communicates regulatory requirements ensuring activities are in compliance with applicable regulations and guidelines
+ Leads documentation of regulatory authority interactions including decisions and outcomes
+ Provides updates at the Global Regulatory Team meetings and project teams as needed
+ Collaborates effectively with regulatory operations leader (ROL)
+ Maintains professional working relationship with colleagues, fostering collaboration, and idea sharing
+ Reviews nonclinical, clinical and CMC documentation (e.g. nonclinical study reports, clinical protocols/study reports, investigator brochures, CMC information/data) and contributes to content as needed
+ Advises team members of major regulatory issues and provides possible solutions and leads the mitigation strategy
+ Leads and coordinates local project team members in developing strategy for applicable documents/activities
+ Ensures the quality and content of all submissions to Health Authorities
+ Leads the regional health authority meetings, liaison with local Health Authority,
+ Document owner of briefing book documentation to Health Authorities
+ Assist with development of the global regulatory functional plan through research, review and interpretation of related product approvals, current regulatory guidance documents and recent public Advisory Committee proceedings to support the successful submission and achievement of target product labeling
+ Accountable in conjunction with the GRL for developing and maintaining the development core data sheet (DCDS) if required
+ Ensure compliance with global regulatory requirements and adherence to regulatory internal policies and processes and coordinate regulatory compliance activities at a global level
+ Provide strategic review of dossier summaries, expert statements, and development management plans
+ Provide updates to the GRT, project teams, and governance boards as needed
+ Leads Global Regulatory Team (GRT), oversees planning and execution of global regulatory activities and submissions
+ May be responsible for creating and reviewing SOPs and regulatory department operating procedures.
Key Core Competencies
+ Strong verbal and written communication skills; interpersonal skills; listening skills; and organizational skills required
+ Unquestionable ethics, professional integrity, and personal values consistent with the SMPA values
+ Ability to work in a diverse environment
+ Demonstrated ability to adapt to changing priorities and work effectively in a matrix organization
+ Demonstrated ability to facilitate appropriate team decisions
+ Sense of urgency and perseverance to achieve results
+ Experience contributing to electronic regulatory submissions and working with regulatory templates
+ Advanced understanding of medical terminology, and FDA and ICH regulations/guidances specific to clinical research and general product development in the pharmaceutical industry
+ Experience reviewing nonclinical, clinical and CMC documentation (e.g. nonclinical study reports, clinical protocols/study reports, investigator brochures, CMC information/data) and contribute to content as needed
+ Understands issues, problems and opportunities by comparing data from different sources to draw conclusions and then can choose a course of action or develop the appropriate solution
+ Proven success/major involvement in NDA/MAA/CTD submissions and approval
+ Capable of effectively negotiating with others while maintaining composure
+ Development and preparation of successful regulatory strategies and the ability to contribute to the development and writing of a regulatory strategy document
+ Ability to learn new therapeutic areas when necessary
+ Prior history with post-marketing/brand optimization strategies and commercial awareness
+ Experience interacting with the FDA and ex-US Health Authorities
+ Experience in successfully leading teams and providing leadership in Health Authority negotiations and meetings
+ Ability to make complex decisions and willingness to defend difficult positions.
+ Comfortable presenting to all levels of the organization including Senior Management.
+ High degree of organizational awareness, ability to connect the dots to understand all the interdependency and big picture
**Education and Experience**
+ Bachelor's degree in a related field required.
+ 8 - 12 years with Master's of relevant experience in biotech or pharmaceutical industry with minimum of 8 years focused in regulatory affairs.
+ Master's degree required (preferably in a scientific discipline)
The base salary range for this role is $187,520 to $234,400. Base salary is part of our total rewards package which also includes the opportunity for merit-based salary increases, short incentive plan participation, eligibility for our 401(k) plan, medical, dental, vision, life and disability insurances and leaves provided in line with your work state. Our robust time-off policy includes flexible paid time off, 11 paid holidays plus additional time off for a shut-down period during the last week of December, 80 hours of paid sick time upon hire and each year thereafter. Total compensation, including base salary to be offered, will depend on elements unique to each candidate, including candidate experience, skills, education and other factors permitted by law.
Disclaimer: The above statements are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel so classified. All personnel may be required to perform duties outside of their normal responsibilities from time to time, as needed.
**Confidential Data** : All information (written, verbal, electronic, etc.) that an employee encounters is considered confidential.
**Compliance** : Achieve and maintain Compliance with all applicable regulatory, legal and operational rules and procedures, by ensuring that all plans and activities for and on behalf of Sumitomo Pharma America (SMPA) and affiliates are carried out with the "best" industry practices and the highest ethical standards.
It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.
**Mental/Physical Requirements** : Fast paced environment handling multiple demands. Must be able to exercise appropriate judgment as necessary. Requires a high level of initiative and independence. Excellent written and oral communication skills required. Requires ability to use a personal computer for extended periods of time.
**Sumitomo Pharma America (SMPA)** **is an Equal Employment Opportunity (EEO) employer**
Qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.
Sumitomo Pharma Co., Ltd., is a global pharmaceutical company based in Japan with operations in the U.S. (Sumitomo Pharma America, Inc.), focused on addressing patient needs in oncology, urology, women's health, rare diseases, cell & gene therapies and CNS. With several marketed products and a diverse pipeline of early- to late-stage investigational assets, we aim to accelerate discovery, research, and development to bring novel therapies to patients sooner. For more information on SMPA, visit our website or follow us on LinkedIn.
Sumitomo Pharma America (SMPA) endeavors to make its application process accessible to all. If you would like to contact us regarding the accessibility of our website or need assistance completing the application process, please contact SMPA at
This contact information is for accommodation requests only and cannot be used to inquire about the status of applications.
At Sumitomo Pharma America, our work is guided by the Sumitomo Pharma mission, vision and values, which tie closely to our company's cultural pillars.
**Our** **Mission**
_To broadly contribute to society through value creation based on innovative research and development activities for the betterment of healthcare and fuller lives of people_ _worldwide_
**Our** **Vision**
_For Longer and Healthier Lives, we unlock the future with cutting edge technology and_ _ideas_