Regulatory Affairs Director Jobs in California
Regulatory Affairs Director jobs in California are among the most active in the country, concentrated in the life sciences, biotechnology, and medical device sectors that anchor the state's economy at every seniority level from newly promoted manager to global regulatory head. The largest hiring volumes are in the San Francisco Bay Area, San Diego, and Los Angeles, where employers such as Genentech, Edwards Lifesciences, and Hologic maintain deep regulatory functions. Demand is strongest in professionals with expertise in FDA submissions, combination products, and international regulatory strategy, particularly for Class II and Class III medical devices and biologics. Find a role that fits below and apply directly.
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Showing 5 of 32+ Regulatory Affairs Director jobs
INTRODUCTION
GLAUKOS - Sr. Manager, Regulatory Affairs
LOCATION: Aliso Viejo, CA
Work Arrangement: Hybrid work schedule
How Will You Make an Impact?
Be at the forefront of innovation – shape regulatory strategies that bring breakthrough therapies and life-changing technologies to patients around the world. At Glaukos, We’ll Go First – and as our next Sr. Manager, Regulatory Affairs, so will you. In this key leadership role, you will drive and support the execution of global regulatory strategies for innovative drug/device combination products and prescription pharmaceuticals. You will lead the preparation of high-quality regulatory submissions, ensure cross-functional alignment, and help shape product development, regulatory approvals, and long-term compliance. Your work will help bring pioneering treatments to patients globally. At Glaukos, we’re a community of innovators focused on transforming the standard of care for chronic eye diseases. With a pioneering spirit and patient-first mindset, we are advancing bold new treatments that improve lives. Join us as we lead the way in sight-saving innovation.
What Will You Do?
Drive Regulatory Strategy and Execution:
- Lead and implement global regulatory strategies for combination products and pharmaceuticals in alignment with development goals.
- Provide strategic regulatory input to interdisciplinary teams on development plans, labeling, and compliance documentation.
- Review and approve internal documents supporting product development and lifecycle activities.
- Represent Regulatory Affairs in cross-functional meetings and project reviews.
- Mentor and guide junior regulatory team members.
Prepare and Submit Regulatory Documentation:
- Oversee the planning, authoring, and coordination of high-quality global submissions (e.g., INDs, CTAs, NDAs, supplements, annual reports).
- Collaborate with subject matter experts to ensure submissions are technically sound, timely, and fully compliant.
- Identify and resolve technical and regulatory challenges during submission development.
Engage with Global Regulatory Authorities:
- Support and lead interactions with U.S. FDA, EMA, and other global health authorities.
- Draft and contribute to briefing packages and manage submission-related communications.
Collaborate and Lead Across Projects:
- Ensure regulatory deliverables are aligned with project timelines and milestones.
- Champion effective cross-functional coordination and regulatory best practices across departments.
Stay Informed and Elevate Best Practices:
- Stay current on FDA, ICH, and EU regulatory changes and trends impacting combination product and pharmaceutical development.
- Help refine internal regulatory systems, submission templates, and document standards.
- Share and implement best practices across the team.
How Will You Get Here?
Education:
- Bachelor’s degree in a scientific discipline required.
- Advanced degree (MS, PharmD, PhD) strongly preferred.
Experience:
- 9+ years of experience in the life sciences industry, including 6+ years in Regulatory Affairs focused on pharmaceuticals and/or combination products.
- Proven experience preparing, leading, and submitting INDs, NDAs, CTAs, and associated amendments and reports.
- Prior involvement in regulatory interactions with FDA and/or EMA.
Knowledge, Skills, and Competencies:
- Deep knowledge of 21 CFR, FDA/ICH guidelines, GxPs, and applicable EU regulatory frameworks.
- Excellent written and verbal communication skills with a collaborative and solutions-oriented mindset.
- Strong critical thinking, project management, and leadership skills.
- Proficiency in Microsoft Office (Word, Excel, PowerPoint); experience with document management systems a plus.
- Regulatory Affairs Certification (RAC) is beneficial.
GKOSUS
INTRODUCTION
GLAUKOS - Sr. Manager, Regulatory Affairs
LOCATION: Aliso Viejo, CA
Work Arrangement: Hybrid work schedule
How Will You Make an Impact?
Be at the forefront of innovation – shape regulatory strategies that bring breakthrough therapies and life-changing technologies to patients around the world. At Glaukos, We’ll Go First – and as our next Sr. Manager, Regulatory Affairs, so will you. In this key leadership role, you will drive and support the execution of global regulatory strategies for innovative drug/device combination products and prescription pharmaceuticals. You will lead the preparation of high-quality regulatory submissions, ensure cross-functional alignment, and help shape product development, regulatory approvals, and long-term compliance. Your work will help bring pioneering treatments to patients globally. At Glaukos, we’re a community of innovators focused on transforming the standard of care for chronic eye diseases. With a pioneering spirit and patient-first mindset, we are advancing bold new treatments that improve lives. Join us as we lead the way in sight-saving innovation.
What Will You Do?
Drive Regulatory Strategy and Execution:
- Lead and implement global regulatory strategies for combination products and pharmaceuticals in alignment with development goals.
- Provide strategic regulatory input to interdisciplinary teams on development plans, labeling, and compliance documentation.
- Review and approve internal documents supporting product development and lifecycle activities.
- Represent Regulatory Affairs in cross-functional meetings and project reviews.
- Mentor and guide junior regulatory team members.
Prepare and Submit Regulatory Documentation:
- Oversee the planning, authoring, and coordination of high-quality global submissions (e.g., INDs, CTAs, NDAs, supplements, annual reports).
- Collaborate with subject matter experts to ensure submissions are technically sound, timely, and fully compliant.
- Identify and resolve technical and regulatory challenges during submission development.
Engage with Global Regulatory Authorities:
- Support and lead interactions with U.S. FDA, EMA, and other global health authorities.
- Draft and contribute to briefing packages and manage submission-related communications.
Collaborate and Lead Across Projects:
- Ensure regulatory deliverables are aligned with project timelines and milestones.
- Champion effective cross-functional coordination and regulatory best practices across departments.
Stay Informed and Elevate Best Practices:
- Stay current on FDA, ICH, and EU regulatory changes and trends impacting combination product and pharmaceutical development.
- Help refine internal regulatory systems, submission templates, and document standards.
- Share and implement best practices across the team.
How Will You Get Here?
Education:
- Bachelor’s degree in a scientific discipline required.
- Advanced degree (MS, PharmD, PhD) strongly preferred.
Experience:
- 9+ years of experience in the life sciences industry, including 6+ years in Regulatory Affairs focused on pharmaceuticals and/or combination products.
- Proven experience preparing, leading, and submitting INDs, NDAs, CTAs, and associated amendments and reports.
- Prior involvement in regulatory interactions with FDA and/or EMA.
Knowledge, Skills, and Competencies:
- Deep knowledge of 21 CFR, FDA/ICH guidelines, GxPs, and applicable EU regulatory frameworks.
- Excellent written and verbal communication skills with a collaborative and solutions-oriented mindset.
- Strong critical thinking, project management, and leadership skills.
- Proficiency in Microsoft Office (Word, Excel, PowerPoint); experience with document management systems a plus.
- Regulatory Affairs Certification (RAC) is beneficial.
GKOSUS
See All 32 Regulatory Affairs Director Jobs in California
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Find JobsRegulatory Affairs Director Jobs by City in California
Where California roles are concentrated, by current openings.
Regulatory Affairs Director Job Market in California
A snapshot from current California openings, updated as new roles post.
Who's Hiring
- Revolution Medicines11
- AbbVie2
- Arrowhead Pharmaceuticals2
- CYTOKINETICS2
- Exelixis2
Top Industries Hiring
- Biotechnology & Pharmaceuticals31
- Medical Devices3
- Healthcare & Medical Services2
What California Employers Look For
The qualifications that appear most often in regulatory affairs director jobs across California.
- Bachelor's or advanced degree in life sciences, engineering, or a related scientific field
- Minimum of seven to ten years of regulatory affairs experience in pharma, biotech, or medical devices
- Demonstrated experience leading FDA submissions including 510(k), PMA, BLA, or NDA filings
- Working knowledge of California Department of Public Health manufacturing and quality regulations
- RAC credential from the Regulatory Affairs Professionals Society strongly preferred by California employers
- Experience managing cross-functional teams and external regulatory consultants or contract research organizations
Regulatory Affairs Director Jobs in California: Frequently Asked Questions
How do you become a regulatory affairs director in California?
Most regulatory affairs directors in California reach the role through a combination of a life sciences degree and progressively senior positions in regulatory submissions, quality assurance, or clinical affairs at a biotech or medical device company. The Regulatory Affairs Professionals Society's RAC credential is widely recognized by California employers and signals formal competency. California does not issue a state-specific license for regulatory affairs, but familiarity with California Department of Public Health manufacturing requirements is a practical asset for senior candidates.
How much do regulatory affairs directors make in California?
Regulatory affairs directors 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 regulatory affairs directors in California?
Employers hiring regulatory affairs directors in California right now include Revolution Medicines, AbbVie, and Arrowhead Pharmaceuticals, based on current listings on Migrate Mate as of June 2026. California's dense concentration of biotech, pharmaceutical, and medical device headquarters means hiring is consistent year-round, with particularly high volume in the Bay Area and San Diego corridors.
Which California cities have the most regulatory affairs director jobs?
Redwood City, Alameda, and San Diego have the most regulatory affairs director openings in California. The Bay Area leads because of its concentration of biopharmaceutical and biotech headquarters, San Diego is driven by its medical device and genomics cluster, and Los Angeles draws demand from pharmaceutical manufacturers and combination product companies with large West Coast operations.
Are there remote regulatory affairs director jobs in California?
Yes, and more than most fields. About 22% of regulatory affairs director openings tied to California are remote or hybrid as of June 2026, reflecting the desk-based and document-intensive nature of much regulatory work. Roles centered on strategy, submissions writing, and agency correspondence tend to be the most flexible, while positions requiring hands-on review of manufacturing facilities or laboratory audits typically require on-site presence.
How can I get hired as a regulatory affairs director in California with little or no experience?
The most realistic entry path is moving into a regulatory affairs specialist or associate role from an adjacent position such as quality assurance, clinical research coordination, or scientific writing at a California biotech or medical device company. Larger employers such as those in the Bay Area and San Diego biotech clusters regularly hire associate regulatory affairs professionals who want to build toward director-level roles. Earning the RAC Foundation credential and building a portfolio of submission-support experience on even one FDA filing meaningfully strengthens a candidate's profile early in their career.
Where can I find and apply to regulatory affairs director jobs in California?
You can find and apply to regulatory affairs director jobs in California on Migrate Mate, which lists current California openings across biotech, pharma, and medical device employers. Find roles that fit your experience and apply directly to each listing.
See All 32 Regulatory Affairs Director Jobs in California
Find roles in California that match your experience and apply in just a few clicks.
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