H-1B Visa Senior Director Regulatory Affairs Jobs
Senior Director Regulatory Affairs roles qualify as H-1B specialty occupations because they require at least a bachelor's degree in a directly related scientific or regulatory field. Pharma, biotech, and medical device companies regularly sponsor H-1B visas for this title, and many file for both initial three-year terms and six-year extensions.
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Get Access To All JobsINTRODUCTION
Septerna is a biotechnology company based in South San Francisco, CA on a mission to develop life-changing medicines for patients with the vision to become the industry-leading G protein-coupled receptor (GPCR)-focused drug discovery company. The company’s Native Complex Platform™ recapitulates GPCRs with their native structure, function, and dynamics outside of the cellular context. This approach enables novel access to modern structural and screening technologies used in industrial-scale drug discovery for the entire class of GPCRs. Septerna has an emerging pipeline of GPCR-targeted small molecule programs with potential for growth to target many GPCRs that have been undruggable and unexploited to date. We are excited to expand our multidisciplinary team of individuals focused on creating revolutionary medicines to address the unmet needs of patients. At Septerna we strive to embrace diversity of thought, expertise, and background through collaboration. To join our ambitious team, be prepared to bring your real self to work every day; grow and learn from a talented team of drug hunters, scientists, and business professionals; and contribute your passion, creativity, and energy to accomplish our mission. We share a fearless pursuit of ground-breaking innovations and cultivate an environment where our employees succeed by learning from each other and working as a team. We are committed to the development of meaningful therapeutics for patients with indications of high unmet need. This is a tremendous opportunity to work with talented individuals on the frontlines of therapeutic discovery and development. You will directly help move therapies through preclinical research, positioning them for success in the clinic. The successful candidate will add their passion, unique talents, and expertise to a dynamic team motivated to discover new disease-modifying therapeutics for patients in a fast-paced environment.
ABOUT THE ROLE
Septerna is seeking an experienced and highly motivated Director/Senior Director of Regulatory Affairs to lead regulatory strategy and execution across our discovery and development programs. This individual will be responsible for developing and implementing regulatory plans and submissions to support preclinical and clinical development, IND/CTA submissions, and interactions with global health authorities. The ideal candidate will bring deep regulatory expertise, strong cross-functional leadership, and a proactive, strategic mindset suited to a fast-paced biotech environment. This position reports into the VP, Regulatory Affairs.
Responsibilities
- Develop and implement regulatory strategies for clinical stage programs, ensuring alignment with business and development objectives.
- Serve as the primary Regulatory Affairs representative on project teams, providing guidance on regulatory requirements and pathways.
- Lead the preparation, review, and submission of high-quality regulatory documents, including INDs, CTAs, amendments, briefing packages, and responses to health authority inquiries.
- Manage interactions with FDA and other global regulatory agencies; coordinate and prepare for regulatory meetings.
- Partner with CMC, Nonclinical, and Clinical teams to ensure compliance with applicable regulations and consistent messaging across submissions.
- Identify regulatory risks and proactively work with cross-functional teams to develop mitigation strategies.
- Monitor the evolving regulatory landscape and communicate implications for Septerna’s programs.
- Support the development of internal regulatory processes, systems, and documentation to enable scalability as the organization grows.
- Mentor and develop junior regulatory staff and contribute to a culture of collaboration and excellence.
QUALIFICATIONS
- Bachelor’s degree in life sciences or a related field; advanced degree (PhD, PharmD, or MS) preferred.
- Prior experience as a Global Regulatory Lead (GRL) preferred.
- 10+ years of experience in Regulatory Affairs within the biopharmaceutical industry, including direct experience leading IND and/or CTA submissions.
- Proven track record of successful interactions with the FDA and other global regulatory agencies.
- Strong understanding of drug development processes, from discovery through clinical stages.
- Excellent project management, organizational, and verbal and written communication skills.
- High attention to detail and accuracy.
- Ability to thrive in a dynamic, fast-paced environment and work effectively across functions.
- Hands-on, strategic thinker with a collaborative and solution-oriented mindset.
COMPENSATION
- The anticipated salary range for candidates who will work in South San Francisco, CA is $235,000 - $285,000. Individual pay may vary based on additional factors, including, and without limitation, job-related skills, experience, work location and relevant education or training. Septerna's compensation package also includes benefits, stock options, and annual target bonus for full-time positions.
Note to Employment Agencies: Please do not forward any agency resumes. The company will not be responsible for any fees related to resumes that are unsolicited.
We are an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.
Septerna participates in the E-Verify program.
California Consumer Privacy Act Privacy Notice For Job Applicants. If you are a California resident, click here for our CCPA Notice.
INTRODUCTION
Septerna is a biotechnology company based in South San Francisco, CA on a mission to develop life-changing medicines for patients with the vision to become the industry-leading G protein-coupled receptor (GPCR)-focused drug discovery company. The company’s Native Complex Platform™ recapitulates GPCRs with their native structure, function, and dynamics outside of the cellular context. This approach enables novel access to modern structural and screening technologies used in industrial-scale drug discovery for the entire class of GPCRs. Septerna has an emerging pipeline of GPCR-targeted small molecule programs with potential for growth to target many GPCRs that have been undruggable and unexploited to date. We are excited to expand our multidisciplinary team of individuals focused on creating revolutionary medicines to address the unmet needs of patients. At Septerna we strive to embrace diversity of thought, expertise, and background through collaboration. To join our ambitious team, be prepared to bring your real self to work every day; grow and learn from a talented team of drug hunters, scientists, and business professionals; and contribute your passion, creativity, and energy to accomplish our mission. We share a fearless pursuit of ground-breaking innovations and cultivate an environment where our employees succeed by learning from each other and working as a team. We are committed to the development of meaningful therapeutics for patients with indications of high unmet need. This is a tremendous opportunity to work with talented individuals on the frontlines of therapeutic discovery and development. You will directly help move therapies through preclinical research, positioning them for success in the clinic. The successful candidate will add their passion, unique talents, and expertise to a dynamic team motivated to discover new disease-modifying therapeutics for patients in a fast-paced environment.
ABOUT THE ROLE
Septerna is seeking an experienced and highly motivated Director/Senior Director of Regulatory Affairs to lead regulatory strategy and execution across our discovery and development programs. This individual will be responsible for developing and implementing regulatory plans and submissions to support preclinical and clinical development, IND/CTA submissions, and interactions with global health authorities. The ideal candidate will bring deep regulatory expertise, strong cross-functional leadership, and a proactive, strategic mindset suited to a fast-paced biotech environment. This position reports into the VP, Regulatory Affairs.
Responsibilities
- Develop and implement regulatory strategies for clinical stage programs, ensuring alignment with business and development objectives.
- Serve as the primary Regulatory Affairs representative on project teams, providing guidance on regulatory requirements and pathways.
- Lead the preparation, review, and submission of high-quality regulatory documents, including INDs, CTAs, amendments, briefing packages, and responses to health authority inquiries.
- Manage interactions with FDA and other global regulatory agencies; coordinate and prepare for regulatory meetings.
- Partner with CMC, Nonclinical, and Clinical teams to ensure compliance with applicable regulations and consistent messaging across submissions.
- Identify regulatory risks and proactively work with cross-functional teams to develop mitigation strategies.
- Monitor the evolving regulatory landscape and communicate implications for Septerna’s programs.
- Support the development of internal regulatory processes, systems, and documentation to enable scalability as the organization grows.
- Mentor and develop junior regulatory staff and contribute to a culture of collaboration and excellence.
QUALIFICATIONS
- Bachelor’s degree in life sciences or a related field; advanced degree (PhD, PharmD, or MS) preferred.
- Prior experience as a Global Regulatory Lead (GRL) preferred.
- 10+ years of experience in Regulatory Affairs within the biopharmaceutical industry, including direct experience leading IND and/or CTA submissions.
- Proven track record of successful interactions with the FDA and other global regulatory agencies.
- Strong understanding of drug development processes, from discovery through clinical stages.
- Excellent project management, organizational, and verbal and written communication skills.
- High attention to detail and accuracy.
- Ability to thrive in a dynamic, fast-paced environment and work effectively across functions.
- Hands-on, strategic thinker with a collaborative and solution-oriented mindset.
COMPENSATION
- The anticipated salary range for candidates who will work in South San Francisco, CA is $235,000 - $285,000. Individual pay may vary based on additional factors, including, and without limitation, job-related skills, experience, work location and relevant education or training. Septerna's compensation package also includes benefits, stock options, and annual target bonus for full-time positions.
Note to Employment Agencies: Please do not forward any agency resumes. The company will not be responsible for any fees related to resumes that are unsolicited.
We are an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.
Septerna participates in the E-Verify program.
California Consumer Privacy Act Privacy Notice For Job Applicants. If you are a California resident, click here for our CCPA Notice.
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Get Access To All JobsTips for Finding H-1B Visa Sponsorship in Senior Director Regulatory Affairs
Align your credentials to SOC code 11-9041
USCIS maps Regulatory Affairs Director roles to this SOC code. Pull the O*NET profile for that code before interviews so you can speak to the specific knowledge areas USCIS expects when adjudicating specialty occupation petitions for this title.
Target employers with active LCA filing history
Use Migrate Mate to filter for companies that have filed Labor Condition Applications specifically for Regulatory Affairs titles. This tells you which employers have already cleared DOL certification for the role, not just who posts job listings.
Verify the prevailing wage tier before negotiating
Run the OFLC Wage Search for SOC 11-9041 in your target metro before you receive an offer. Your employer must pay at least the prevailing wage level certified on the LCA, so knowing the floor protects you during salary negotiations.
Document international regulatory submissions as evidence
USCIS RFEs for senior-level regulatory roles often challenge whether the position truly requires a specialized degree. Compile a record of FDA, EMA, or ICH submission projects you led, demonstrating that the job function is inseparable from scientific and regulatory expertise.
Confirm your employer files before the April cap deadline
H-1B registration opens in March for an October 1 start. If you're currently on OPT, confirm your prospective employer will submit the registration in time. A missed deadline means waiting a full year, so get written confirmation of their intended filing timeline early in the process.
Ask whether the role is cap-exempt
Some regulatory affairs roles at nonprofit research institutions, academic medical centers, or government contractors qualify for cap-exempt H-1B status through USCIS, allowing filing at any time without lottery selection. Confirm the employer's entity type before assuming you need to wait for the next cap cycle.
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Find Senior Director Regulatory Affairs JobsSenior Director Regulatory Affairs H-1B Visa: Frequently Asked Questions
Does a Senior Director Regulatory Affairs role qualify as an H-1B specialty occupation?
Yes. USCIS consistently recognizes senior regulatory affairs positions as specialty occupations because the role requires theoretical and practical application of highly specialized regulatory science, typically requiring at least a bachelor's degree in pharmacy, chemistry, biology, or a related field. Directors overseeing FDA submissions, clinical regulatory strategy, or post-market compliance routinely receive H-1B approval under this standard.
Which industries sponsor H-1B visas most frequently for this role?
Pharmaceutical, biotechnology, and medical device companies account for the majority of H-1B sponsorships for Senior Director Regulatory Affairs titles. Contract research organizations and diagnostics manufacturers also file regularly. You can browse current openings at employers with verified LCA filing history for this title on Migrate Mate, which surfaces companies already cleared through the DOL certification process.
Can I transfer my H-1B to a new regulatory affairs employer mid-petition?
Yes. Under H-1B portability rules, you can start working for a new employer as soon as the new I-129 petition is filed with USCIS, without waiting for approval, as long as your previous H-1B was approved and you've maintained valid status. Your new employer must file a new LCA certified by DOL before submitting the transfer petition.
Does a foreign regulatory affairs degree qualify for H-1B specialty occupation purposes?
Foreign degrees are accepted if they're equivalent to a U.S. bachelor's or higher in a directly related field. USCIS typically requires a credential evaluation from a recognized evaluation service to confirm equivalency. For Senior Director roles, degrees in pharmaceutical sciences, regulatory affairs, chemistry, or biology from accredited foreign institutions generally satisfy the educational requirement when properly evaluated.
How does the H-1B six-year cap apply to regulatory affairs professionals pursuing permanent residency?
The standard H-1B cap is six years, split into two three-year terms. If your employer files a PERM labor certification or I-140 immigrant petition at least 365 days before your six-year limit, you can extend your H-1B in one-year increments beyond that cap under the American Competitiveness in the 21st Century Act. Regulatory affairs professionals in the EB-2 or EB-3 categories commonly use this extension pathway while awaiting priority date movement.
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