1,246 Environmental Protection Agency jobs in the United States

Stanford University invites applications for a tenure-track Assistant Professor in the field of Global Environmental Policy within the Department of Environmental Social Sciences. The scope of the search is broad, and we welcome applications from scholars studying environmental policy issues from the perspective of the quantitative social sciences or related fields, including candidates who have completed or will soon complete their PhD in economics, political science, environmental policy, or data science as applied to environmental policy. The successful candidate will serve as faculty within the Department of Environmental Social Sciences, at the Stanford Doerr School of Sustainability.
Application packages should be submitted online at this LINK ( . Review of applications will begin Dec 1, 2025, and to guarantee full consideration, your application should be submitted by this date.
Candidates for an untenured position at the rank of assistant professor must have a PhD or be enrolled in a PhD program or equivalent international degree-granting program at the time of application, with expected degree completion by date of appointment as an assistant professor. Candidates should demonstrate evidence of a creative research trajectory, interest in the quantitative analysis of topics related to environmental policy, and a commitment to excellence in teaching at both graduate and undergraduate levels. Applicants for an untenured position must include with their application:
1. a cover letter,
2. CV,
3. a combined research and teaching statement of no more than three pages,
4. graduate school transcripts,
5. a writing sample,
6. name and contact information for three professional references.
The Environmental Social Sciences Department, Stanford Doerr School of Sustainability and Stanford University value faculty who will help foster an open and respectful academic environment for colleagues, students, and staff with a wide range of backgrounds, and perspectives. Candidates may choose to include as part of their research and teaching statements a brief discussion about how their work and experience will further these values.
Stanford is an equal employment opportunity and affirmative action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other characteristic protected by law. Stanford welcomes applications from all who would bring additional dimensions to the University's research, teaching and clinical missions.
Consistent with its obligations under the law, the University will provide reasonable accommodations to applicants and employees with disabilities. Applicants requiring a reasonable accommodation for any part of the application or hiring process should contact
The expected nine-month base pay range for this position is $143,500 - $180,000.
Stanford University has provided a base pay range representing its good faith estimate of what the university reasonably expects to pay for the position. The pay offered to the selected candidate will be determined based on factors including (but not limited to) the experience and qualifications of the selected candidate including years since terminal degree, training, and field or discipline; departmental budget availability; internal equity; and external market pay for comparable jobs.
For general questions regarding this position, please contact Marisa MacAskill at

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at Function:**
Regulatory Affairs Group
**Job Sub** **Function:**
Regulatory Affairs
**Job Category:**
Professional
**All Job Posting Locations:**
Raynham, Massachusetts, United States of America
**Job Description:**
At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at .
**About MedTech**
Fueled by innovation at the intersection of biology and technology, we're developing the next generation of smarter, less invasive, more personalized treatments.
Your unique talents will help patients on their journey to wellness. Learn more at & Johnson announced plans to separate our Orthopaedics business to establish a standalone orthopaedics company, operating as DePuy Synthes. The process of the planned separation is anticipated to be completed within 18 to 24 months, subject to legal requirements, including consultation with works councils and other employee representative bodies, as may be required, regulatory approvals and other customary conditions and approvals.
Should you accept this position, it is anticipated that, following conclusion of the transaction, you would be an employee of DePuy Synthes and your employment would be governed by DePuy Synthes employment processes, programs, policies, and benefit plans. In that case, details of any planned changes would be provided to you by DePuy Synthes at an appropriate time and subject to any necessary consultation processes.
An internal pre-identified candidate for consideration has been identified. However, all applications will be considered.
We are searching for the best talent for a **Regulatory Affairs Analyst** .
**Duties / Responsibilities:**
+ Project management by maintaining multiple tracking logs for tracking and reporting project status and resource availability
+ Maintaining compliance pertaining to Medical Device Listings and Establishment Registrations
+ Effectively initiate, track, and monitor purchase orders and invoices to ensure payments are processed in the company electronic systems in a timely manner
+ Coordinate logistics for internal and external audits, including on-site and desk audits
+ Assist with general department responsibilities, such as setting up department meetings, archiving physical and electronic documentation, coordinating regulatory submissions locally and internationally, tracking submission details and metrics, distributing department communication, etc.
+ Monitor and respond to international requests
+ Arrange logistics for international visits
+ Perform other job-related duties as assigned
**Qualifications / Requirements:**
+ Minimum of a bachelor's degree required. Desired fields of study include science, engineering (e.g., biomedical, electrical, software, mechanical), business, legal, or similar.
+ Minimum two years of experience in a highly regulated industry, preferably in medical device or pharmaceutical.
+ Interaction with and support for company executives and department staff
+ Proficiency of Microsoft Office (Word, Excel, Outlook, PowerPoint, etc.) and other electronic systems
+ Able to create reports and manipulate data
+ Strong analytical skills
+ Flexibility - able to adapt to compliance cycle activities and demanding timelines
+ Must be well-organized and able to multitask and work with limited supervision
+ Strong team player
+ Proactive, taking initiative when needed
+ Ability to prioritize and seek guidance on prioritization when needed.
+ Must have excellent written and verbal communication skills, with collaborative attitude and strong attention to detail
**Additional Information:**
+ The anticipated base pay range for this position is 74,000 to 119,600.
+ The Company maintains highly competitive, performance-based compensation programs. Under current guidelines, this position is eligible for an annual performance bonus in accordance with the terms of the applicable plan. The annual performance bonus is a cash bonus intended to provide an incentive to achieve annual targeted results by rewarding for individual and the corporation's performance over a calendar/performance year. Bonuses are awarded at the Company's discretion on an individual basis.
+ Employees and/or eligible dependents may be eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance.
+ Employees may be eligible to participate in the Company's consolidated retirement plan (pension) and savings plan (401(k)).
+ This position is eligible to participate in the Company's long-term incentive program.
+ Employees are eligible for the following time off benefits:
+ Vacation -120 hours per calendar year
+ Sick time - 40 hours per calendar year
+ Holiday pay, including Floating Holidays -13 days per calendar year
+ Work, Personal and Family Time - up to 40 hours per calendar year
+ Parental Leave - 480 hours within one year of the birth/adoption/foster care of a child
+ Condolence Leave - 30 days for an immediate family member: 5 days for an extended family member
+ Caregiver Leave - 10 days
+ Volunteer Leave - 4 days
+ Military Spouse Time-Off - 80 hours
+ Additional information can be found through the link below. job posting is anticipated to close on **October 25, 2025** . The Company may however extend this time-period, in which case the posting will remain available on to accept additional applications.
_Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act._
_Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants' needs. If you are an individual with a disability and would like to request an accommodation, please contact us via_ _ _or contact AskGS to be directed to your accommodation resource._
#LI-Hybrid
**The anticipated base pay range for this position is :**
74,000 to 119,600
Additional Description for Pay Transparency:
The Company maintains highly competitive, performance-based compensation programs. Under current guidelines, this position is eligible for an annual performance bonus in accordance with the terms of the applicable plan. The annual performance bonus is a cash bonus intended to provide an incentive to achieve annual targeted results by rewarding for individual and the corporation's performance over a calendar/performance year. Bonuses are awarded at the Company's discretion on an individual basis. - Employees and/or eligible dependents may be eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance. - Employees may be eligible to participate in the Company's consolidated retirement plan (pension) and savings plan (401(k)). - This position is eligible to participate in the Company's long-term incentive program. - Employees are eligible for the following time off benefits: - Vacation -120 hours per calendar year - Sick time - 40 hours per calendar year - Holiday pay, including Floating Holidays -13 days per calendar year - Work, Personal and Family Time - up to 40 hours per calendar year - Parental Leave - 480 hours within one year of the birth/adoption/foster care of a child - Condolence Leave - 30 days for an immediate family member: 5 days for an extended family member - Caregiver Leave - 10 days - Volunteer Leave - 4 days - Military Spouse Time-Off - 80 hours - Additional information can be found through the link below.

**Working with Us**
Challenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You'll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams. Take your career farther than you thought possible.
Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives. Read more: careers.bms.com/working-with-us .
RayzeBio, a Bristol Myers Squibb company, is a dynamic biotechnology company headquartered in San Diego, CA. The company is focused on improving survival of people with cancer by harnessing the power of targeted radioisotopes. RayzeBio is developing innovative drugs against targets of solid tumors. Led by a successful and experienced entrepreneurial team, RayzeBio aims to be the global leader in radiopharmaceuticals.
**Position Summary**
The Regulatory Affairs Intern will support the Regulatory Affairs team in preparing documentation, tracking submissions, and assisting with project coordination. This internship offers exposure to regulatory processes in the pharmaceutical industry and provides hands-on experience in a cross-functional environment.
The full-time internship will take place June - August 2026.
**Responsibilities**
Essential duties and responsibilities include the following. Other duties may be assigned.
+ Regulatory Documentation Support
+ Assist in organizing and formatting regulatory submission documents (e.g., IND, CTA, briefing packages, nonclinical reports)
+ Help maintain submission trackers and document repositories
+ Review documents for consistency and completeness under supervision
+ Project Coordination
+ Support the creation and updating of project timelines and task lists
+ Attend team meetings and take notes on action items and follow-ups
+ Help prepare meeting agendas and distribute materials
+ Cross-functional Communication
+ Coordinate with internal teams to gather required documentation
+ Draft internal communications and summaries for regulatory updates
+ Shadow cross-functional meetings to understand regulatory integration
+ Research and Compliance
+ Conduct literature reviews and regulatory intelligence gathering
+ Assist in compiling summaries of relevant FDA/EMA guidance documents
+ Help monitor changes in regulatory requirements and flag updates to the team
**Basic Qualifications**
+ Currently pursuing a Bachelor's degree in Sciences, Life Sciences, Pharmacy, Public Health, Engineering or related field
+ Strong interest in regulatory affairs and drug development
+ Excellent organizational and communication skills
+ All candidates must be authorized to work in the US both at the time of hire and for the duration of their employment. Please note that immigration or visa sponsorship is not available for this position.
**Preferred Qualifications**
+ Familiarity with Microsoft Office Suite (Word, Excel, PowerPoint, Outlook) and Adobe Acrobat
+ Experience with project management tools (e.g., Smartsheet, MS Project) is a plus
+ Prior internship or coursework related to clinical trials or regulatory science
**Skills and Attributes**
+ Detail-oriented and able to manage multiple tasks
+ Strong written and verbal communication skills
+ Professional, proactive, and eager to learn
+ Ability to work collaboratively in a dynamic, cross-functional environment
This is a temporary, time-bound position intended for the duration of the internship or co-op program. Employment in this role does not imply or guarantee ongoing or permanent employment with BMS.
The starting hourly compensation for this assignment is within the range of $20.00 to $42.00/hr. Please note that the final individual compensation and any applicable benefits will be determined by your employer of record (and not BMS). Factors influencing this decision may include the characteristics of the assignment, such as demonstrated experience, required skill, and the geographic location of the job. Compensation details are subject to change.
If you come across a role that intrigues you but doesn't perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career.
**Compensation Overview:**
The starting compensation range(s) for this role are listed above for a full-time employee (FTE) basis. Additional incentive cash and stock opportunities (based on eligibility) may be available. The starting pay rate takes into account characteristics of the job, such as required skills, where the job is performed, the employee's work schedule, job-related knowledge, and experience. Final, individual compensation will be decided based on demonstrated experience.
Eligibility for specific benefits listed on our careers site may vary based on the job and location. For more on benefits, please visit offerings are subject to the terms and conditions of the applicable plans then in effect and may include the following: Medical, pharmacy, dental and vision care. Wellbeing support such as the BMS Living Life Better program and employee assistance programs (EAP). Financial well-being resources and a 401(K). Financial protection benefits such as short- and long-term disability, life insurance, supplemental health insurance, business travel protection and survivor support. Work-life programs include paid national holidays and optional holidays, Global Shutdown Days between Christmas and New Year's holiday, up to 120 hours of paid vacation, up to two (2) paid days to volunteer, sick time off, and summer hours flexibility. Parental, caregiver, bereavement, and military leave. Family care services such as adoption and surrogacy reimbursement, fertility/infertility benefits, support for traveling mothers, and child, elder and pet care resources. Other perks like tuition reimbursement and a recognition program.
**Uniquely Interesting Work, Life-changing Careers**
With a single vision as inspiring as Transforming patients' lives through science , every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in a supportive culture, promoting global participation in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.
**On-site Protocol**
BMS has an occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role:
Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function.
BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to . Visit careers.bms.com/ ( eeo-accessibility to access our complete Equal Employment Opportunity statement.
BMS cares about your well-being and the well-being of our staff, customers, patients, and communities. As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters.
BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.
If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information: data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.
**Company:** Bristol-Myers Squibb
**Req Number:** R
**Updated:** :49:58.368 UTC
**Location:** Indianapolis-IN
Bristol Myers Squibb is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, protected veteran status, pregnancy, citizenship, marital status, gender expression, genetic information, political affiliation, 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, 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_

**Regulatory Affairs Analyst**
**Date:** Oct 10, 2025
**Location(s):** Juno Beach, FL, US, 33408
**Company:** NextEra Energy
**Requisition ID:** 90691
Florida Power & Light Company is the largest electric utility in the U.S., providing reliable energy to nearly 12 million Floridians. With one of the nation's most fuel-efficient, cost-effective power generation fleets and industry-leading reliability, we're redefining what's possible in energy. Want to be part of something powerful? Join our outstanding team and help shape the future of energy.
**Position Specific Description**
Employees in this role support Florida Power and Light's (FPL) Regulatory Affairs team and are involved in the Company's projects and dockets that are filed with the Florida Public Service Commission (FPSC). This position collaborates with different business units and involves familiarity with a variety of regulatory concepts, practices, and procedures.
**Job Duties & Responsibilities**
+ Coordinates regulatory filings and proceedings
+ Leads and plans docket team meetings, develops project timelines, reviews petitions and testimony, manages discovery, summarizes key milestones, and attends hearings
+ Summarizes and reports on changes in complex rates regulations and any expected impacts on the Company
+ Monitors state and national regulatory proceedings and provides timely summaries to leadership
+ Masters standard concepts, practices, and procedures of the state's regulatory proceedings
+ Performs other job-related duties as assigned
**Requirements**
+ Bachelor's Degree or higher
+ 4+ years of relevant experience
+ Strong writing and research skills - expected to demonstrate expertise through summarizing complex filings
+ Highly effective communication and analytical skills
+ Willingness and ability to work extended hours when needed
+ Strong dedication to customer service and completing assignments
+ Ability to multi-task and maintain high performance under pressure in a dynamic, fast-paced environment
**Job Overview**
Employees in this role participate in all activities relating to government compliance. Individuals maintain the organization's ongoing relationships with regulatory commissions/authorities. This positon is responsible for coordinating regulatory filings and proceedings including but not limited to: planning docket team, developing project timelines, reviewing petition and testimony, managing discovery, summarizing key milestones and attending hearings.
**Job Duties & Responsibilities**
+ Coordinates regulatory filings and proceedings
+ Leads and plans docket team meetings, develops project timelines, reviews petitions and testimony, manages discovery, summarizes key milestones, and attends hearings
+ Summarizes and reports on changes in complex rates regulations and any expected impacts on the Company
+ Monitors state and national regulatory proceedings and provides timely summaries to leadership
+ Masters standard concepts, practices, and procedures of the state's regulatory proceedings
+ Performs other job-related duties as assigned
**Required Qualifications**
+ High School Grad / GED
+ Bachelor's or Equivalent Experience
+ Experience: 2+ years
**Preferred Qualifications**
+ None
NextEra Energy offers a wide range of benefits to support our employees and their eligible family members. Clickto learn more.
**Employee Group:** Exempt
**Employee Type:** Full Time
**Job Category:** Legal/Regulatory/External Affairs
**Organization:** Florida Power & Light Company
**Relocation Provided:** No
NextEra Energy is an Equal Opportunity Employer. Qualified applicants are considered for employment without regard to race, color, age, national origin, religion, marital status, sex, sexual orientation, gender identity, gender expression, genetics, disability, protected veteran status or any other basis prohibited by law.
NextEra Energy provides reasonable accommodation in its application and selection process for qualified individuals, including accommodations related to compliance with conditional job offer requirements, consistent with federal, state, and local laws. Supporting medical or religious documentation will be required where applicable and permitted by applicable law. To request a reasonable accommodation, please send an e-mail to, providing your name, telephone number and the best time for us to reach you. Alternatively, you may call . Please do not use this line to inquire about your application status.
NextEra Energy will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor's legal duty to furnish information.
NextEra Energy **does not** accept any unsolicited resumes or referrals from **any third-party recruiting firms or agencies** . Please see ourfor more information.