Senior Director Regulatory Affairs Jobs in California
Senior Director Regulatory Affairs jobs in California represent one of the most active and competitive markets in the country, concentrated in life sciences, medical devices, and pharmaceuticals across the San Francisco Bay Area, San Diego, and Los Angeles. Major employers with deep California roots include Johnson & Johnson, Genentech, and Edwards Lifesciences, with openings at every level from regulatory manager to senior director. The most sought-after specialties are FDA submissions strategy, combination products, and biologics regulatory affairs. Find a role that fits below and apply directly.
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Showing 5 of 7+ 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 7 Senior Director Regulatory Affairs Jobs in California
Find roles in California that match your experience and apply in just a few clicks.
Find JobsSenior Director Regulatory Affairs Jobs by City in California
Where California roles are concentrated, by current openings.
Senior Director Regulatory Affairs Job Market in California
A snapshot from current California openings, updated as new roles post.
Who's Hiring
- Revolution Medicines2
- CYTOKINETICS1
- Exelixis1
- Insmed1
- Nurix Therapeutics1
Top Industries Hiring
- Biotechnology & Pharmaceuticals7
What California Employers Look For
The qualifications that appear most often in senior director regulatory affairs jobs across California.
- Bachelor's or advanced degree in life sciences, pharmacy, chemistry, or a related field
- Minimum ten years of regulatory affairs experience in pharmaceuticals, biologics, or medical devices
- Demonstrated experience leading FDA submissions including NDAs, BLAs, PMAs, or 510(k)s
- Strong knowledge of applicable regulations including 21 CFR, ICH guidelines, and EU MDR
- Proven ability to lead and develop cross-functional regulatory teams in a matrix organization
- RAC certification from the Regulatory Affairs Professionals Society preferred by most California employers
Senior Director Regulatory Affairs Jobs in California: Frequently Asked Questions
How do you become a senior director regulatory affairs in California?
Reaching a senior director regulatory affairs role in California typically requires an advanced degree in a life sciences discipline combined with extensive experience in FDA-regulated industries. Most California employers expect deep expertise in a specific product category such as biologics, combination products, or Class III devices. Earning the Regulatory Affairs Certification from the Regulatory Affairs Professionals Society strengthens candidacy. California's dense cluster of biotech and medtech companies means progression often moves through mid-level regulatory manager and director roles at companies in the Bay Area or San Diego corridor.
How much do senior director regulatory affairses make in California?
Senior director regulatory affairses in California earn a median of about $96,980 a year, based on May 2025 Bureau of Labor Statistics wage data, ranging from around $57,530 for the lowest 10% to over $158,280 for the top 10%. Pay rises with experience, specialty, and employer.
Which companies hire senior director regulatory affairss in California?
Employers hiring senior director regulatory affairss in California right now include Revolution Medicines, CYTOKINETICS, and Exelixis, based on current listings on Migrate Mate as of June 2026. California's concentration of FDA-regulated life sciences companies means openings appear consistently across both established pharmaceutical manufacturers and fast-growing biotech and medical device firms headquartered in the state.
Which California cities have the most senior director regulatory affairs jobs?
The cities with the most senior director regulatory affairs openings in California are Redwood City, Alameda, and Brisbane. The San Francisco Bay Area leads because of its massive biotech cluster anchored by companies like Genentech and Gilead, while San Diego's medtech and genomics sector drives strong demand there, and Los Angeles attracts openings from a broader mix of pharmaceutical and combination product companies.
Are there remote senior director regulatory affairs jobs in California?
Yes, and more than most fields, given that regulatory affairs work is largely documentation, strategy, and agency communication rather than hands-on lab or manufacturing work. About 29% of senior director regulatory affairs openings tied to California are remote or hybrid as of June 2026, reflecting the desk-based nature of the role. The functions most commonly performed remotely include submission writing, regulatory strategy development, and agency correspondence, while roles requiring close collaboration with clinical or manufacturing teams tend to require on-site presence.
How can I get hired as a senior director regulatory affairs in California with little or no experience?
The most realistic entry path is through a regulatory affairs associate or specialist role at a California-based biotech or medical device company, where you build direct FDA submission experience. Large California employers including Genentech, Abbott, and Intuitive Surgical run rotational programs and hire into junior regulatory roles that serve as the pipeline to senior leadership. Moving laterally from clinical affairs, quality assurance, or scientific affairs is a recognized route because those roles share regulatory touchpoints. Earning the Regulatory Affairs Certification early signals commitment and gives candidates from adjacent backgrounds a concrete credential edge.
Where can I find and apply to senior director regulatory affairs jobs in California?
You can find and apply to senior director regulatory affairs jobs in California on Migrate Mate, which lists current California openings for this role. Find the roles that fit your background and apply directly to the employers posting them.
See All 7 Senior Director Regulatory Affairs Jobs in California
Find roles in California that match your experience and apply in just a few clicks.
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