101 Legal jobs in Columbus

**Overview** **The Work** The Legal Translator will play a critical role in providing high-quality translation services in the legal field. This position performs all duties and responsibilities in accordance with the Mission, Vision, and Core Values of Cayuse. **Responsibilities** **Key Responsibilities** + Provide written translation services for legal documents including letters, reports, website content, posters, brochures, general information documents, correspondence, etc. + Preserve the original content, meaning and tone of the document. + Translators must accurately depict cultural sensitivity and clarity. + Edit and proofread translated documents to ensure accuracy, clarity, and adherence to legal terminology. + Must be able to conduct a Quality edit proof process when assigned for review. + Translators are required to follow style guides, glossaries, and our clients' preferences. + Ensure confidentiality and security of all translated materials. + Stay up to date with legal terminology and industry's best practices. + Other duties as assigned. **Qualifications** **Qualifications - Here's What You Need** + High School Diploma or 4 years of experience. + Fluency in one of the following languages: + Spanish, Vietnamese, Russian, Mandarin, Cantonese, and Somali. + Must have one of the following certifications: + Legal Translation online certifications. + CTP (Certified Translation Professional). + ATA (American Translators Association). + AOC (Administrative Office of the Court). + Membership to NAJIT ( National Association of Judiciary Interpreters and Translators). + Experience working in: + State Department. + Refugees. + Court/ Legal setting. + Familiarity with Legal Terminology. + Experience with Publications. + Must be able to pass a background check. May require additional background checks as required by projects and/or clients at any time during employment. **Minimum Skills Required:** + Must possess problem-solving skills. + Exceptional written communication skills. + Ability to respond effectively to customers with a sense of urgency. + Highly motivated with the ability to handle and manage multiple tasks at any one time. + Ability to forge new relationships, individual and teaming in nature. + Must be a Self-starter, that can work independently and as part of a team. **Preferred Qualifications:** + Bachelor's degree in a foreign language, linguistics or a related field. **Reports to: Program Manager** **Working Conditions** + This position is on-call on a as needed basis. Interpreters will be notified within 48 hours of potential jobs. + This position requires Legal Translation within the Washington State. + Must be physically and mentally able to perform duties extended periods of time. + May be asked to work a flexible schedule which may include holidays. + May be asked to work hours outside of normal business hours. **Other Duties:** _Please note this job description is not designed to cover or contain a comprehensive list of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice._ **_Cayuse is an Equal Opportunity Employer. All employment decisions are based on merit, qualifications, skills, and abilities. All qualified applicants will receive consideration for employment in accordance with any applicable federal, state, or local law._** **Pay Range** USD $45.00 - USD $65.00 /Hr. Submit a Referral ( **Can't find the right opportunity?** Join ourTalent Community ( orLanguage Services Talent Community ( and be among the first to discover exciting new possibilities! **Location** _US-_ **ID** _ _ **Category** _Language Services_ **Position Type** _Full-Time Hourly Non Exempt_ **Remote** _Yes_ **Clearance Required** _None_

**Overview** **The Work** The Legal Translator will play a critical role in providing high-quality translation services in the legal field. This position performs all duties and responsibilities in accordance with the Mission, Vision, and Core Values of Cayuse. **Responsibilities** **Key Responsibilities** + Provide written translation services for legal documents including letters, reports, website content, posters, brochures, general information documents, correspondence, etc. + Preserve the original content, meaning and tone of the document. + Translators must accurately depict cultural sensitivity and clarity. + Edit and proofread translated documents to ensure accuracy, clarity, and adherence to legal terminology. + Must be able to conduct a Quality edit proof process when assigned for review. + Translators are required to follow style guides, glossaries, and our clients' preferences. + Ensure confidentiality and security of all translated materials. + Stay up to date with legal terminology and industry's best practices. + Other duties as assigned. **Qualifications** **Qualifications - Here's What You Need** + High School Diploma or 4 years of experience. + Fluency in one of the following languages: + Spanish, Vietnamese, Russian, Mandarin, Cantonese, and Somali. + Must have one of the following certifications: + Legal Translation online certifications. + CTP (Certified Translation Professional). + ATA (American Translators Association). + AOC (Administrative Office of the Court). + Membership to NAJIT ( National Association of Judiciary Interpreters and Translators). + Experience working in: + State Department. + Refugees. + Court/ Legal setting. + Familiarity with Legal Terminology. + Experience with Publications. + Must be able to pass a background check. May require additional background checks as required by projects and/or clients at any time during employment. **Minimum Skills Required:** + Must possess problem-solving skills. + Exceptional written communication skills. + Ability to respond effectively to customers with a sense of urgency. + Highly motivated with the ability to handle and manage multiple tasks at any one time. + Ability to forge new relationships, individual and teaming in nature. + Must be a Self-starter, that can work independently and as part of a team. **Preferred Qualifications:** + Bachelor's degree in a foreign language, linguistics or a related field. **Reports to: Program Manager** **Working Conditions** + This position is on-call on a as needed basis. Interpreters will be notified within 48 hours of potential jobs. + This position requires Legal Translation within the Washington State. + Must be physically and mentally able to perform duties extended periods of time. + May be asked to work a flexible schedule which may include holidays. + May be asked to work hours outside of normal business hours. **Other Duties:** _Please note this job description is not designed to cover or contain a comprehensive list of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice._ **_Cayuse is an Equal Opportunity Employer. All employment decisions are based on merit, qualifications, skills, and abilities. All qualified applicants will receive consideration for employment in accordance with any applicable federal, state, or local law._** **Pay Range** USD $45.00 - USD $65.00 /Hr. Submit a Referral ( **Can't find the right opportunity?** Join ourTalent Community ( orLanguage Services Talent Community ( and be among the first to discover exciting new possibilities! **Location** _US-_ **ID** _ _ **Category** _Language Services_ **Position Type** _Full-Time Hourly Non Exempt_ **Remote** _Yes_ **Clearance Required** _None_

**Job Summary**
Provides legal advice to clients on complex matters.
Combines knowledge of one or more legal specialties with sound business acumen, and knowledge of business goals and objectives.
Has significant experience and subject matter expertise.
**Essential Functions**
+ Resolves legal issues and provides proactive, business-savvy legal advice and counsel.
+ Manages complex matters.
+ Retains and supervises/manages outside counsel on select matters.
+ Anticipates internal/external business and regulatory issues and provides applicable legal advice.
+ Reviews and revises legal documents.
+ Negotiates with outside parties on contractual issues and legal disputes.
+ Assists in training clients on legal issues.
+ Communicates with clients regarding status updates
**Required Experience**
+ 5+ years focused securities/corporate governance experience
+ Provide legal advice on complex matters related to the New York Stock Exchange, Securities and Exchange Commission and various state corporate laws, including:
+ Preparing and reviewing SEC filings - 10-K, 8-K, proxy statements
+ Both '33 and '34 Act reporting
+ Executive Compensation matters and short and long-term incentive plans
+ Knowledge and understanding of corporate governance and board of directors support
+ Budgetary responsibility
**Preferred Experience:**
+ Utility or other regulated industry
+ Representing public corporations
+ Corporate transactional is a plus
+ Treasury and financial transactional is a plus
The preceding description is not designed to be a complete list of all duties and responsibilities required of the position.
_As a public utility, NiSource is required to provide continuous service to customers at all times. To ensure we fulfill that obligation, employees may be required to work outside their normal work hours and perform tasks outside of their normal responsibilities in support of emergency operations._
**Work Authorization**
Authorized to work in the United States without requiring sponsorship.
**Workplace Connection**
Value inclusion within your day to day responsibilities by respecting others perspectives/convictions, engaging others opinions, creating a safe environment where people, ideas, and opinions are valued within your Team/Customers and external partners.
Respect the unique lived experiences within your Team/Customers and external work partners by valuing different world views, challenges, and cultures that represents all walks of life and all backgrounds.
Treat others with respect and consideration. Actively participate in creating and contributing to a positive work environment.
**Equal Employment Opportunity**
NiSource is committed to providing equal employment opportunities in each of its companies to all employees and applicants for employment without regard to race, color, religion, national origin or ancestry, veteran status, disability, gender, age, marital status, sexual orientation, gender identity, sex (including pregnancy, lactation, childbirth or related medical conditions), genetic information, citizenship status, or any protected group status as defined by law. Each employee is expected to abide by this principle.
**By applying, you may be considered for other job opportunities.**
**ADA Accommodations**
If you need a reasonable accommodation to participate in any part of the hiring process or to perform the essential functions of the position, please contact OneHR at or
**Safety Statement**
Promote a safe work environment by actively participating in all aspects of our employee safety program. Report any unsafe conditions and take actions to prevent personal injuries. Support our interdependent safety culture by ensuring the safety of your co-workers. Stay focused on the task at hand and promote productivity through good work habits.
**E-Verify**
NiSource participates in the U.S. Department of Homeland Security's E-Verify program. As part of this process, we provide the following notices to all job applicants: These documents inform you of your rights and responsibilities under U.S. law. You can view or download them using the links below:
+ **E-Verify Poster** (English and Spanish) E-Verify Participation Poster English and Spanish ( **Right to Work Poster** (English and Spanish) If you have the right to work, don't let anyone take it away ( Range*:**
$155,400.00 - $233,100.00
**_*The salary offered to a candidate is_** **_based on several factors including_** **_but not limited to_** **_the_** **_candidate's skills, job-related knowledge, and relevant experience_** **_, as well as internal pay equity_** **_._**
**Posting Start Date:**

**Posting End Date (if applicable):**
**Please note that the job posting will close on the day before the posting end date.**
At NiSource, you'll be part of the team serving nearly four million customers throughout the Midwest and Mid-Atlantic, who count on us to energize their homes and businesses. Whether speaking with customers by phone, analyzing financial data or installing new gas lines in a neighborhood, you'll meet exciting challenges each day and make the most of your skills and talents. And you'll be part of a company that was named by Forbes magazine as one of America's Best Large Employers.
We're looking for talent from all backgrounds. We invite candidates of all abilities to come as they are and do what they love. Through our years of successful growth, we've stayed true to our roots by making a difference in the lives of millions of our customers. If you're interested in joining an inclusive, innovative company that fosters opportunity for growth, NiSource might be the place for you.

**Summary:**
Meta is seeking a Public Affairs Manager to join Public Affairs Legal and Regulatory team. This role will support media engagement and public affairs strategy across US state policy issues, state and local strategies, and major litigation matters.
**Required Skills:**
Public Affairs Manager, Legal and Regulatory Responsibilities:
1. Support development of communications plans for major litigation issues
2. Manage inbound media inquiries for legal and litigation issues
3. Help develop relationships with key media at the state and national level
4. Support implementation of state policy communications plans and announcements at the state and local media level
**Minimum Qualifications:**
Minimum Qualifications:
5. 6+ years experience in communications, with media engagement experience
6. Experience quickly understanding and explaining complex legal and regulatory issues in straightforward terms
7. Cross-functional partner management and collaboration skills
8. Experience balancing multiple work streams simultaneously
9. Experience using AI tools in a communications role
10. Experience developing both long and short term public affairs strategies
**Preferred Qualifications:**
Preferred Qualifications:
11. Background in policy or legal communications roles
12. Experience at Meta
13. Existing reporter relationships in the tech or policy space
**Public Compensation:**
$145,000/year to $204,000/year + bonus + equity + benefits
**Industry:** Internet
**Equal Opportunity:**
Meta is proud to be an Equal Employment Opportunity and Affirmative Action employer. We do not discriminate based upon race, religion, color, national origin, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender, gender identity, gender expression, transgender status, sexual stereotypes, age, status as a protected veteran, status as an individual with a disability, or other applicable legally protected characteristics. We also consider qualified applicants with criminal histories, consistent with applicable federal, state and local law. Meta participates in the E-Verify program in certain locations, as required by law. Please note that Meta may leverage artificial intelligence and machine learning technologies in connection with applications for employment.
Meta is committed to providing reasonable accommodations for candidates with disabilities in our recruiting process. If you need any assistance or accommodations due to a disability, please let us know at

Our work matters. We help people get the medicine they need to feel better and live well. We do not lose sight of that. It fuels our passion and drives every decision we make.
**Job Posting Title**
Director, Compliance (Regulatory) - Remote
**Job Description**
The Director of Compliance is responsible for the successful development, implementation and execution of Prime's compliance program. This position is accountable for advising and consulting with business area leadership in the execution of the program and associated work plan within a given business area.
**Responsibilities**
+ Manages a team of experienced compliance managers
+ Provides consultation to internal and external leaders regarding escalated legal and compliance issues, regulatory and client audits; serves as primary contact for assigned internal business leaders and clients
+ Responsible for ensuring operating areas are in compliance with regulatory requirements; ensures that all appropriate local, state, and federal regulations are followed
+ Provides compliance advice, investigates complaints and verifies deficiencies are corrected; oversees CAP management and findings
+ Consults on regulatory change management process and program and advises on areas of organizational risk
+ Supports the Chief Compliance Officer's reporting to the Corporate Compliance Committee and the Compliance and Audit Committee
+ Promotes awareness and communication of compliance and ethics
+ Other duties as assigned
**Minimum Qualifications**
+ Bachelor's degree in business or related area of study, or equivalent combination of education and/or relevant work experience; HS diploma or GED is required
+ 8 years of work experience in legal, compliance, or related field
+ 5 years of leadership/people management experience
+ Must be eligible to work in the United States without need for work visa or residency sponsorship
Must be eligible to work in the United States without the need for work visa or residency sponsorship
**Additional Qualifications**
+ Demonstrated frequent use of and general knowledge of industry practices, techniques, and standards
+ Communicates effectively through both verbal and written communication
+ Demonstrated ability to organize and structure work to focus on the areas of most importance
+ Works effectively with others in different functions or groups
**Preferred Qualifications**
+ Advanced degree in a relevant discipline (JD, MBA, MHA, etc.)
+ PBM/health care experience
Every employee must understand, comply with and attest to the security responsibilities and security controls unique to their job, and comply with all applicable legal, regulatory, and contractual requirements and internal policies and procedures
Every employee must be able to perform the essential functions of the job and, if requested, reasonable accommodations will be made to enable employees with disabilities to perform the essential functions, absent undue hardship. In addition, Prime retains the right to change or assign other duties to this job.
ob.
Potential pay for this position ranges from $108,000.00 - $184,000.00 based on experience and skills.
To review our Benefits, Incentives and Additional Compensation, visit our Benefits Page ( and click on the "Benefits at a glance" button for more detail.
_Prime Therapeutics LLC is proud to be an equal opportunity and affirmative action employer. We encourage diverse candidates to apply, and all qualified applicants will receive consideration for employment without regard to_ _race, color, religion, gender, sex (including pregnancy), national origin, disability, age, veteran status, or any other legally protected class under federal, state, or local law._ _ _
_We welcome people of different backgrounds, experiences, abilities, and perspectives including qualified applicants with arrest and conviction records and any qualified applicants requiring reasonable accommodations in accordance with the law._
_Prime Therapeutics LLC is a Tobacco-Free Workplace employer._
Positions will be posted for a minimum of five consecutive workdays.
Prime Therapeutics' fast-paced and dynamic work environment is ideal for proactively addressing the constant changes in today's health care industry. Our employees are involved, empowered, and rewarded for their achievements. We value new ideas and work collaboratively to provide the highest quality of care and service to our members.
If you are looking to advance your career within a growing, team-oriented, award-winning company, apply to Prime Therapeutics today and start making a difference in people's lives.
Prime Therapeutics LLC is proud to be an equal opportunity and affirmative action employer. We encourage diverse candidates to apply, and all qualified applicants will receive consideration for employment without regard to race, color, religion, gender, sex (including pregnancy), national origin, disability, age, veteran status, or any other legally protected class under federal, state, or local law.     
We welcome people of different backgrounds, experiences, abilities, and perspectives including qualified applicants with arrest and conviction records and any qualified applicants requiring reasonable accommodations in accordance with the law.
Prime Therapeutics LLC is a Tobacco-Free Workplace employer.
If you are an applicant with a disability and need a reasonable accommodation for any part of the employment process, please contact Human Resources at or email

**Job Description**
**Principal Program Manager, Global AI Legal & Regulatory Strategy**
As Program Manager for Oracle's AI Legal & Regulatory group within the IP & Development legal organization, you will play a pivotal role in shaping Oracle's global approach to artificial intelligence (AI) legal and regulatory matters. You will design, drive, and oversee critical legal and compliance programs, ensuring that Oracle's legal teams are aligned, informed, and prepared to navigate the rapidly evolving AI regulatory landscape. Your technical acumen, process orientation, and experience with regulatory implementation will be essential to your success. This is a high-impact role for a motivated, tech-savvy program manager who excels at driving results and collaborating across legal, technical, and business domains.
**Experience** :
+ 7+ years of experience in program management within legal, regulatory, compliance, or risk functions; preferably with PAAS/IAAS, SaaS, or enterprise software environment.
+ Demonstrated experience designing, implementing, and managing legal, compliance or regulatory management programs (e.g., GDPR, EU AI Act, CCPA, technology regulations).
**Technical & Process Orientation:**
+ Comfortable engaging with technical concepts (AI/ML, privacy by design) and translating them into legal, policy, or compliance processes; Proven ability to build, document, and drive the adoption of end-to-end legal processes in a complex, matrixed organization.
+ Program Execution - Define and manage projects scope, objectives, workstreams, success metrics, reporting frameworks, communication plans, and enablement strategies.
+ Process Improvement & Operational Optimization - Manage operations for the legal group across varying topics, identify critical topics & implement process enhancements to drive scale, agility, & effectiveness to promote legal and business collaboration.
+ Excellent organizational and scheduling management skills, managing multiple priorities simultaneously
**Soft Skills** :
+ Highly detail-oriented, organized, and process-driven, yet capable of strategic thinking and innovation.
+ Excellent interpersonal skills; able to communicate clearly with legal, technical, and business executives.
**Education** :
+ Bachelor's degree required; JD, MBA, or relevant advanced degree preferred.
**Responsibilities**
**Strategic Program Leadership**
+ Design, implement, and manage cross-functional programs related to AI legal and regulatory readiness, compliance, and risk mitigation.
+ Translate regulatory developments and legal strategies into structured, actionable projects with clear outcomes, measures of success, and reporting mechanisms.
**Program & Stakeholder Management**
+ Partner closely with senior legal, compliance, privacy, and technical leaders across Oracle to align program objectives with organizational priorities and regulatory obligations.
+ Champion collaboration across legal functions and business units; facilitate stakeholder buy-in and execution with clear, consistent communication.
**Regulatory Change Management**
+ Lead Oracle's legal responses to new and emerging global AI regulatory requirements.
+ Develop end-to-end processes for legal review, compliance implementation, and ongoing monitoring; drive adoption and training as needed.
**Program Execution & Governance**
+ Define and manage project lifecycles-scoping, planning, deliverable tracking, KPIs, executive reporting, and enablement strategies.
+ Implement and optimize governance structures for cross-legal coordination, ensuring robust documentation and compliance with Oracle policies.
**Process Improvement & Operational Excellence**
+ Assess existing processes to identify opportunities for consolidation, automation, or enhancement.
+ Implement innovative solutions and best practices to scale compliance efforts, improve transparency, and support the legal team's ability to do more with less.
**Agile & Data-Driven Execution**
+ Promote agile methodologies and continuous value delivery; ensure adaptability to fast-changing legal and regulatory environments.
+ Use data and analytics to drive decisions, measure success, and communicate impact across stakeholder groups.
#LI-KA1
Disclaimer:
**Certain US customer or client-facing roles may be required to comply with applicable requirements, such as immunization and occupational health mandates.**
**Range and benefit information provided in this posting are specific to the stated locations only**
US: Hiring Range in USD from: $97,500 to $199,500 per annum. May be eligible for bonus and equity.
Oracle maintains broad salary ranges for its roles in order to account for variations in knowledge, skills, experience, market conditions and locations, as well as reflect Oracle's differing products, industries and lines of business.
Candidates are typically placed into the range based on the preceding factors as well as internal peer equity.
Oracle US offers a comprehensive benefits package which includes the following:
1. Medical, dental, and vision insurance, including expert medical opinion
2. Short term disability and long term disability
3. Life insurance and AD&D
4. Supplemental life insurance (Employee/Spouse/Child)
5. Health care and dependent care Flexible Spending Accounts
6. Pre-tax commuter and parking benefits
7. 401(k) Savings and Investment Plan with company match
8. Paid time off: Flexible Vacation is provided to all eligible employees assigned to a salaried (non-overtime eligible) position. Accrued Vacation is provided to all other employees eligible for vacation benefits. For employees working at least 35 hours per week, the vacation accrual rate is 13 days annually for the first three years of employment and 18 days annually for subsequent years of employment. Vacation accrual is prorated for employees working between 20 and 34 hours per week. Employees working fewer than 20 hours per week are not eligible for vacation.
9. 11 paid holidays
10. Paid sick leave: 72 hours of paid sick leave upon date of hire. Refreshes each calendar year. Unused balance will carry over each year up to a maximum cap of 112 hours.
11. Paid parental leave
12. Adoption assistance
13. Employee Stock Purchase Plan
14. Financial planning and group legal
15. Voluntary benefits including auto, homeowner and pet insurance
The role will generally accept applications for at least three calendar days from the posting date or as long as the job remains posted.
Career Level - IC4
**About Us**
As a world leader in cloud solutions, Oracle uses tomorrow's technology to tackle today's challenges. We've partnered with industry-leaders in almost every sector-and continue to thrive after 40+ years of change by operating with integrity.
We know that true innovation starts when everyone is empowered to contribute. That's why we're committed to growing an inclusive workforce that promotes opportunities for all.
Oracle careers open the door to global opportunities where work-life balance flourishes. We offer competitive benefits based on parity and consistency and support our people with flexible medical, life insurance, and retirement options. We also encourage employees to give back to their communities through our volunteer programs.
We're committed to including people with disabilities at all stages of the employment process. If you require accessibility assistance or accommodation for a disability at any point, let us know by emailing or by calling in the United States.
Oracle is an Equal Employment Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, sexual orientation, gender identity, disability and protected veterans' status, or any other characteristic protected by law. Oracle will consider for employment qualified applicants with arrest and conviction records pursuant to applicable law.

**Summary:**
Meta is seeking a Public Affairs Manager to join Public Affairs Legal and Regulatory team. This role will support media engagement and public affairs strategy across US state policy issues, state and local strategies, and major litigation matters.
**Required Skills:**
Public Affairs Manager, Legal and Regulatory Responsibilities:
1. Support development of communications plans for major litigation issues
2. Manage inbound media inquiries for legal and litigation issues
3. Help develop relationships with key media at the state and national level
4. Support implementation of state policy communications plans and announcements at the state and local media level
**Minimum Qualifications:**
Minimum Qualifications:
5. 6+ years experience in communications, with media engagement experience
6. Experience quickly understanding and explaining complex legal and regulatory issues in straightforward terms
7. Cross-functional partner management and collaboration skills
8. Experience balancing multiple work streams simultaneously
9. Experience using AI tools in a communications role
10. Experience developing both long and short term public affairs strategies
**Preferred Qualifications:**
Preferred Qualifications:
11. Background in policy or legal communications roles
12. Experience at Meta
13. Existing reporter relationships in the tech or policy space
**Public Compensation:**
$145,000/year to $204,000/year + bonus + equity + benefits
**Industry:** Internet
**Equal Opportunity:**
Meta is proud to be an Equal Employment Opportunity and Affirmative Action employer. We do not discriminate based upon race, religion, color, national origin, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender, gender identity, gender expression, transgender status, sexual stereotypes, age, status as a protected veteran, status as an individual with a disability, or other applicable legally protected characteristics. We also consider qualified applicants with criminal histories, consistent with applicable federal, state and local law. Meta participates in the E-Verify program in certain locations, as required by law. Please note that Meta may leverage artificial intelligence and machine learning technologies in connection with applications for employment.
Meta is committed to providing reasonable accommodations for candidates with disabilities in our recruiting process. If you need any assistance or accommodations due to a disability, please let us know at

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 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, a diverse pipeline of early- to late-stage assets, and in-house advanced technology capabilities, 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_