Senior Director Regulatory Affairs Jobs in USA with Visa Sponsorship
Senior Director Regulatory Affairs roles are sponsored under the H-1B visa, requiring an advanced degree in a scientific or regulatory field. Employers file a Labor Condition Application and I-129 petition on your behalf. Most positions are with pharmaceutical, biotech, or medical device companies that sponsor regularly. For detailed occupation requirements, see the O*NET profile.
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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 Senior Director Regulatory Affairs Jobs
Target established life sciences companies
Large pharmaceutical, biotech, and medical device companies have dedicated immigration teams and sponsor H-1B visas routinely. Smaller startups may lack the infrastructure to navigate USCIS petitions for senior regulatory roles, making established employers a safer bet.
Emphasize your degree field, not just your title
H-1B specialty occupation requires a degree directly related to the role. A master's or PhD in regulatory affairs, pharmacy, chemistry, or a life sciences discipline strengthens your petition significantly over a general business or unrelated STEM degree.
Highlight FDA, EMA, or ICH regulatory experience
Senior Director roles require demonstrable leadership across submissions, IND, NDA, or 510(k) filings. Employers sponsoring at this level need to justify the position's complexity to USCIS, so your track record with major regulatory agencies directly supports their petition.
Negotiate sponsorship before accepting an offer
At the Senior Director level, visa sponsorship is often negotiable. Raise the topic explicitly during offer discussions, not after signing. Confirm the employer will cover legal fees and premium processing, which significantly reduces your H-1B approval timeline.
Get clarity on cap-exempt employer status
Universities, nonprofit research institutions, and certain government-affiliated organizations are exempt from the H-1B annual cap and lottery. If a Senior Director role exists at a cap-exempt employer, you can apply year-round without waiting for the April lottery window.
Prepare detailed documentation of your regulatory leadership scope
USCIS scrutinizes senior-level H-1B petitions for specialty occupation qualification. Provide organizational charts, descriptions of your direct reports, and evidence of cross-functional regulatory strategy responsibilities. Vague job descriptions increase the likelihood of a Request for Evidence.
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Find Senior Director Regulatory Affairs JobsFrequently Asked Questions
Can a Senior Director of Regulatory Affairs get H-1B sponsorship?
Yes. Senior Director Regulatory Affairs roles qualify as H-1B specialty occupations because they typically require at least a bachelor's degree in a specific scientific or regulatory field. Most employers in pharma, biotech, and medical devices sponsor this title regularly. At the senior director level, petitions generally have strong approval rates when the degree-to-role connection is clearly documented.
What degree do I need for H-1B sponsorship in this role?
A bachelor's degree at minimum is required, but most employers sponsoring at the Senior Director level expect a master's degree or PhD in pharmacy, chemistry, biology, regulatory science, or a closely related discipline. A general business degree alone is unlikely to satisfy USCIS specialty occupation requirements unless paired with substantial relevant coursework or a combination of education and experience.
How do I find companies actively sponsoring Senior Director Regulatory Affairs roles?
Migrate Mate filters job listings specifically for visa-sponsoring employers, making it the most efficient way to identify companies actively hiring at this level with H-1B support. Look for large pharmaceutical companies, contract research organizations, and established medical device manufacturers, as these categories file H-1B petitions for regulatory leadership roles most consistently.
Will USCIS issue a Request for Evidence for a Senior Director H-1B petition?
RFEs are more common for senior-level petitions because USCIS sometimes questions whether a director-level title truly requires a specific degree rather than broad management experience. The strongest petitions include detailed position descriptions, the organizational hierarchy, evidence of technical regulatory duties, and documentation that the role cannot be performed without specialized academic training in the field.
Can I transfer my H-1B to a new employer as a Senior Director?
Yes. H-1B portability allows you to start working for a new employer as soon as the transfer petition is filed, without waiting for approval, provided you're maintaining valid status. Your new employer files a fresh I-129. At the Senior Director level, ensure your new employer is prepared to document specialty occupation requirements thoroughly, as USCIS reviews transfer petitions with the same scrutiny as initial filings.
What is the prevailing wage requirement for sponsored Senior Director Regulatory Affairs jobs?
U.S. employers sponsoring a visa must pay at least the prevailing wage, which is what workers in the same role, area, and experience level typically earn. The Department of Labor sets this rate to make sure companies aren't hiring foreign workers simply because they'd accept lower pay than a U.S. worker. It varies by job title, location, and experience. You can look up current prevailing wage rates for any occupation and location using the OFLC Wage Search page.
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