Senior Director Regulatory Affairs Jobs
Senior Director Regulatory Affairs jobs are open across pharmaceuticals, medical devices, biotechnology, and consumer health, from senior director to VP and C-suite-adjacent levels, with specializations in drug development, combination products, and global regulatory strategy. Find a role that fits from the openings below and apply directly.
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Showing 5 of 23+ Senior Director Regulatory Affairs jobs
SUMMARY/JOB PURPOSE:
Responsible for driving the development and implementation of global regulatory strategies that align with asset and corporate goals as well as health authority requirements. Ensures timely preparation of organized, consistent, and scientifically valid submissions. Provides expertise in translating regulatory requirements into practical, workable plans. Communicates clearly and proactively with stakeholders to reduce regulatory risk and drive the implementation of appropriate mitigation strategies.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
- Interact directly with regulatory authorities.
- Conduct effective and timely regulatory intelligence and research to provide guidance to study and asset teams. Provide risk assessments and recommendations for various regulatory scenarios, including possible expedited pathways.
- Represent Regulatory Affairs in multi-disciplinary teams to establish development and regulatory strategies for early and late-stage development programs.
- Work with external vendors to plan, review, prepare, submit, and maintain CTAs in Europe, Asia, and other regions.
- Review clinical trial-related documentation (e.g., protocols, informed consents, clinical study reports) for compliance with regulatory guidance and alignment with study objectives and regulatory strategy.
- Lead, author and evaluate documents submitted to regulatory health authorities to ensure they are complete, organized, of high quality, contain appropriate messaging and compliant with applicable regional regulations.
- Oversee the preparation and completion of regulatory submissions (electronic and paper), including investigational new drug applications, supplements and amendments, IND safety reports, annual reports/DSURs, other routine amendments, and new drug applications (NDA)/biologics license applications (BLA).
- Contribute to the implementation of processes and procedures, including developing and authoring internal work instructions and company SOPs.
- Lead multiple assets and/or studies as assigned.
SUPERVISORY RESPONSIBILITIES:
- Directly supervise employees.
EDUCATION/EXPERIENCE/KNOWLEDGE & SKILLS:
Education/Experience:
- Bachelor’s degree in related discipline and a minimum of fifteen years of related experience; or,
- Master’s degree in related discipline and a minimum of thirteen years of related experience; or,
- PhD degree in related discipline and a minimum of twelve years of related experience; or,
- Equivalent combination of education and experience.
Experience/The Ideal for Successful Entry into Job:
Knowledge/Skills:
- Develops and manages plans, establishes timelines, sets standards for performance. Manages and effectively communicates priorities. Motivates self and others to achieve business objectives and deliver results for areas of responsibility. Resourceful and persistent in overcoming obstacles, even when confronted with ambiguity or barriers. Takes pride in delivering high quality work.
- Applies extensive knowledge of regulatory requirements, industry drivers and practices to develop innovative approaches and manage the work of a team. Anticipates potential changes and challenges the status quo to drive continuous improvement.
- Develops and manages plans, establishes timelines, sets standards for performance and balances commitments to complete multiple activities and achieve results for areas of responsibility.
- Strong interpersonal skills and demonstrable ability to accommodate differing views to influence an agreed upon resolution. Identifies potential for conflict and takes preventive action.
- Effective builder of cohesive teams, facilitates team alignment and achievement of common goals. Independently engages internal and external stakeholders to establish productive collaborative relationships.
- Establishes objectives for areas of responsibility and plans for successful outcomes, consistent with Regulatory Affairs strategy.
- Demonstrates advanced skill and insight in gathering, analyzing and applying key information to solve complex problems. Provides regulatory expertise to cross-functional teams. Understands longer term consequences of decisions and actions.
- Effectively leads and manages a team, acting with integrity to build trust and execute on team objectives and departmental goals. Serves as a role model, encouraging others to behave ethically; takes accountability for self and group actions.
JOB COMPLEXITY:
- Capable of proactively assessing workload, trends, tasks and priorities for cross-functional activity.
- Plans and executes multiple projects or activities, considering alternative methods and contingency plans to avoid potential issues.
- Designs and implements solutions to address cross functional project level challenges, taking into consideration the broader impact.
- Engages, influences and collaborates with stakeholders on cross-functional projects.
WORKING CONDITIONS:
- Travel approximately 20%
DISCLAIMER
The preceding job description has been designed to indicate the general nature and level of work performed by employees within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities and qualifications required of employees assigned to the job.
We are an Equal Opportunity Employer and do not discriminate against any employee or applicant for employment because of race, color, sex, age, national origin, religion, sexual orientation, gender identity, status as a veteran, and basis of disability or any other federal, state, or local protected class.
Notice to Recruiters/Staffing Agencies
Recruiters and staffing agencies should not contact Exelixis, Inc. through this page. We require that all recruiters and staffing agencies have a signed contract on file and be assigned a specific search by our human resources department. Any resumes submitted through the website or directly by recruiters or staffing agencies that do not meet the above-mentioned criteria will be considered unsolicited and the company will not be responsible for any related fees.
Our compensation reflects the cost of labor across several U.S. geographic markets, and we pay differently based on those defined markets. The base pay range for this position is $248,000 - $352,500 annually. The base pay range may take into account the candidate’s geographic region, which will adjust the pay depending on the specific work location. The base pay offered will take into account the candidate’s geographic region, job-related knowledge, skills, experience and internal equity, among other factors.
In addition to the base salary, as part of our Total Rewards program, Exelixis offers comprehensive employee benefits package, including a 401k plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts. Employees are also eligible for a discretionary annual bonus program, or if field sales staff, a sales-based incentive plan. Exelixis also offers employees the opportunity to purchase company stock, and receive long-term incentives, 15 accrued vacation days in their first year, 17 paid holidays including a company-wide winter shutdown in December, and up to 10 sick days throughout the calendar year.
If you have a disability and need an accommodation in relation to the application and/or recruitment process, please email us at: recruiting@exelixis.com.
WORKING CONDITIONS:
Our office is a modern space that fosters collaboration and creativity. Teams work closely together, sharing ideas and solutions in a supportive atmosphere. We provide all necessary equipment, including dual monitors and ergonomic chairs, to ensure a comfortable workspace.
DISCLAIMER:
The preceding job description has been designed to indicate the general nature and level of work performed by employees within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities and qualifications required of employees assigned to the job.
We are an Equal Opportunity Employer and do not discriminate against any employee or applicant for employment because of race, color, sex, age, national origin, religion, sexual orientation, gender identity, status as a veteran, and basis of disability or any other federal, state or local protected class.
SUMMARY/JOB PURPOSE:
Responsible for driving the development and implementation of global regulatory strategies that align with asset and corporate goals as well as health authority requirements. Ensures timely preparation of organized, consistent, and scientifically valid submissions. Provides expertise in translating regulatory requirements into practical, workable plans. Communicates clearly and proactively with stakeholders to reduce regulatory risk and drive the implementation of appropriate mitigation strategies.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
- Interact directly with regulatory authorities.
- Conduct effective and timely regulatory intelligence and research to provide guidance to study and asset teams. Provide risk assessments and recommendations for various regulatory scenarios, including possible expedited pathways.
- Represent Regulatory Affairs in multi-disciplinary teams to establish development and regulatory strategies for early and late-stage development programs.
- Work with external vendors to plan, review, prepare, submit, and maintain CTAs in Europe, Asia, and other regions.
- Review clinical trial-related documentation (e.g., protocols, informed consents, clinical study reports) for compliance with regulatory guidance and alignment with study objectives and regulatory strategy.
- Lead, author and evaluate documents submitted to regulatory health authorities to ensure they are complete, organized, of high quality, contain appropriate messaging and compliant with applicable regional regulations.
- Oversee the preparation and completion of regulatory submissions (electronic and paper), including investigational new drug applications, supplements and amendments, IND safety reports, annual reports/DSURs, other routine amendments, and new drug applications (NDA)/biologics license applications (BLA).
- Contribute to the implementation of processes and procedures, including developing and authoring internal work instructions and company SOPs.
- Lead multiple assets and/or studies as assigned.
SUPERVISORY RESPONSIBILITIES:
- Directly supervise employees.
EDUCATION/EXPERIENCE/KNOWLEDGE & SKILLS:
Education/Experience:
- Bachelor’s degree in related discipline and a minimum of fifteen years of related experience; or,
- Master’s degree in related discipline and a minimum of thirteen years of related experience; or,
- PhD degree in related discipline and a minimum of twelve years of related experience; or,
- Equivalent combination of education and experience.
Experience/The Ideal for Successful Entry into Job:
Knowledge/Skills:
- Develops and manages plans, establishes timelines, sets standards for performance. Manages and effectively communicates priorities. Motivates self and others to achieve business objectives and deliver results for areas of responsibility. Resourceful and persistent in overcoming obstacles, even when confronted with ambiguity or barriers. Takes pride in delivering high quality work.
- Applies extensive knowledge of regulatory requirements, industry drivers and practices to develop innovative approaches and manage the work of a team. Anticipates potential changes and challenges the status quo to drive continuous improvement.
- Develops and manages plans, establishes timelines, sets standards for performance and balances commitments to complete multiple activities and achieve results for areas of responsibility.
- Strong interpersonal skills and demonstrable ability to accommodate differing views to influence an agreed upon resolution. Identifies potential for conflict and takes preventive action.
- Effective builder of cohesive teams, facilitates team alignment and achievement of common goals. Independently engages internal and external stakeholders to establish productive collaborative relationships.
- Establishes objectives for areas of responsibility and plans for successful outcomes, consistent with Regulatory Affairs strategy.
- Demonstrates advanced skill and insight in gathering, analyzing and applying key information to solve complex problems. Provides regulatory expertise to cross-functional teams. Understands longer term consequences of decisions and actions.
- Effectively leads and manages a team, acting with integrity to build trust and execute on team objectives and departmental goals. Serves as a role model, encouraging others to behave ethically; takes accountability for self and group actions.
JOB COMPLEXITY:
- Capable of proactively assessing workload, trends, tasks and priorities for cross-functional activity.
- Plans and executes multiple projects or activities, considering alternative methods and contingency plans to avoid potential issues.
- Designs and implements solutions to address cross functional project level challenges, taking into consideration the broader impact.
- Engages, influences and collaborates with stakeholders on cross-functional projects.
WORKING CONDITIONS:
- Travel approximately 20%
DISCLAIMER
The preceding job description has been designed to indicate the general nature and level of work performed by employees within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities and qualifications required of employees assigned to the job.
We are an Equal Opportunity Employer and do not discriminate against any employee or applicant for employment because of race, color, sex, age, national origin, religion, sexual orientation, gender identity, status as a veteran, and basis of disability or any other federal, state, or local protected class.
Notice to Recruiters/Staffing Agencies
Recruiters and staffing agencies should not contact Exelixis, Inc. through this page. We require that all recruiters and staffing agencies have a signed contract on file and be assigned a specific search by our human resources department. Any resumes submitted through the website or directly by recruiters or staffing agencies that do not meet the above-mentioned criteria will be considered unsolicited and the company will not be responsible for any related fees.
Our compensation reflects the cost of labor across several U.S. geographic markets, and we pay differently based on those defined markets. The base pay range for this position is $248,000 - $352,500 annually. The base pay range may take into account the candidate’s geographic region, which will adjust the pay depending on the specific work location. The base pay offered will take into account the candidate’s geographic region, job-related knowledge, skills, experience and internal equity, among other factors.
In addition to the base salary, as part of our Total Rewards program, Exelixis offers comprehensive employee benefits package, including a 401k plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts. Employees are also eligible for a discretionary annual bonus program, or if field sales staff, a sales-based incentive plan. Exelixis also offers employees the opportunity to purchase company stock, and receive long-term incentives, 15 accrued vacation days in their first year, 17 paid holidays including a company-wide winter shutdown in December, and up to 10 sick days throughout the calendar year.
If you have a disability and need an accommodation in relation to the application and/or recruitment process, please email us at: recruiting@exelixis.com.
WORKING CONDITIONS:
Our office is a modern space that fosters collaboration and creativity. Teams work closely together, sharing ideas and solutions in a supportive atmosphere. We provide all necessary equipment, including dual monitors and ergonomic chairs, to ensure a comfortable workspace.
DISCLAIMER:
The preceding job description has been designed to indicate the general nature and level of work performed by employees within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities and qualifications required of employees assigned to the job.
We are an Equal Opportunity Employer and do not discriminate against any employee or applicant for employment because of race, color, sex, age, national origin, religion, sexual orientation, gender identity, status as a veteran, and basis of disability or any other federal, state or local protected class.
See All Senior Director Regulatory Affairs Jobs
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Find JobsSenior Director Regulatory Affairs Job Market
A snapshot from current openings nationwide, updated as new roles post.
Who's Hiring
- Insmed Incorporated4
- Revolution Medicines4
- Lupin2
- BeOne Medicines1
Top Industries Hiring
- Biotechnology & Pharmaceuticals16
- Distribution & Wholesale4
- Science & Research2
- Consulting & Professional Services1
- Energy1
What Employers Look For
The qualifications that appear most often in senior director regulatory affairs jobs.
- Bachelor's or advanced degree in life sciences, pharmacy, chemistry, or a related field
- 10 or more years of regulatory affairs experience in pharmaceutical, biotech, or medical device sectors
- Direct experience leading FDA submissions such as NDAs, BLAs, 510(k)s, or PMAs
- Demonstrated ability to manage cross-functional teams and lead regulatory strategy across product lifecycles
- Familiarity with ICH guidelines, 21 CFR regulations, and international regulatory frameworks
- Regulatory Affairs Certification (RAC) from RAPS preferred or required by many employers
Tips for Your Senior Director Regulatory Affairs Job Search
Tailor your resume to submission types
Hiring managers want to see which submission types you've owned, whether NDAs, BLAs, 510(k)s, or PMAs. List the specific pathway, the product type, and whether you led the strategy or the execution. Generic regulatory experience won't differentiate you at the director level.
Apply early to roles that fit
Migrate Mate lists senior director regulatory affairs openings from across the United States in one place, so you can find roles that match and apply directly to each listing.
Quantify your regulatory approval outcomes
Approvals, timelines compressed, and submissions completed are the metrics that resonate with hiring committees. If you've reduced a submission cycle from 18 months to 12, say so. Directors who can translate regulatory work into business outcomes stand out against candidates who list only responsibilities.
Target openings by agency interaction level
Some roles are primarily internal, while others require frequent FDA meetings, Type B interactions, or agency correspondence. Identify which type fits your background and filter accordingly when you search, so your cover letter speaks directly to the scope the employer actually needs.
Prepare a 90-day regulatory plan for interviews
Senior director interviews often include a strategic scenario: how would you assess the regulatory posture here and what would you prioritize? Preparing a brief, structured framework, covering pipeline review, SOP gaps, and agency relationship audit, gives you a concrete answer ready to go.
Negotiate scope before you negotiate title
At this level, reporting structure and budget authority matter as much as compensation. Before your final interview round, clarify whether the role owns the regulatory strategy or executes someone else's, and whether you'd have direct FDA communication authority. Misalignment on scope is a common reason senior hires leave within the first year.
Senior Director Regulatory Affairs Jobs: Frequently Asked Questions
Which companies are hiring the most senior director regulatory affairss?
The companies hiring the most senior director regulatory affairss right now include Insmed Incorporated, Lupin, and Revolution Medicines, with the largest share of openings in California, Florida, and New Jersey, based on current listings on Migrate Mate as of June 2026. Pharmaceutical manufacturers and medical device companies consistently account for the majority of postings at this level.
How many senior director regulatory affairs jobs are remote?
About 30% of senior director regulatory affairs openings are fully remote or hybrid as of June 2026, reflecting the document-intensive and meeting-heavy nature of the role. Positions focused on regulatory strategy, submissions management, and policy tend to offer the most remote flexibility, while roles requiring frequent lab or manufacturing site presence are more commonly on-site.
How do you become a senior director regulatory affairs?
Most senior directors start with a life sciences degree, then build hands-on experience in regulatory roles at the associate or manager level before advancing to director. Earning a Regulatory Affairs Certification from RAPS strengthens your candidacy. Leading at least one major submission from strategy through approval, and developing experience managing a regulatory team, are the milestones that typically precede promotion to senior director.
Can you get hired as a senior director regulatory affairs without direct leadership experience?
It's uncommon to be hired as a senior director without prior people management experience, but some companies will promote strong individual contributors who have led cross-functional submission teams or served as regulatory lead on a complex program. If you're missing formal direct reports, emphasize project leadership, mentorship of junior staff, and any instances where you set regulatory strategy across an organization. Smaller companies and startups are more open to candidates building toward the full leadership profile.
What does the senior director regulatory affairs interview process look like?
The process typically involves an initial screen with a recruiter or HR partner, followed by a technical interview with the VP of Regulatory or Chief Regulatory Officer focused on submission experience and agency interaction history. A panel round with cross-functional peers from clinical, legal, and commercial is common. Final rounds often include a strategic presentation or case study where you walk through how you'd approach the regulatory posture for a pipeline asset or product issue.
Where can I find and apply to senior director regulatory affairs jobs?
You can find and apply to senior director regulatory affairs jobs on Migrate Mate, which lists current openings from employers across the United States. Search for roles that match your submission expertise, therapeutic area, and preferred work arrangement, then apply directly to each listing that fits.
See All Senior Director Regulatory Affairs Jobs
Jump back to the full list of openings and apply to any senior director regulatory affairs role that fits.
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