TN Visa Senior Director Regulatory Affairs Jobs
Senior Director Regulatory Affairs roles qualify for TN visa sponsorship under the USMCA's Scientific Technician/Technologist and Scientist categories, typically supported by a life sciences or chemistry degree. Canadian citizens can secure TN status at the border or preclearance sites; Mexican citizens apply at a U.S. consulate. Employers in pharma, biotech, and medical device sectors routinely sponsor this position.
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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 TN Visa Sponsorship as a Senior Director Regulatory Affairs
Align your credentials to TN categories
Regulatory Affairs directors most often qualify under the Scientist or Scientific Technician category. Confirm your degree field maps directly to that category before applying, since a mismatch in credential classification is one of the most common TN denial reasons at the border.
Target FDA-regulated industries first
Pharma, biologics, and Class II/III medical device companies have established regulatory affairs departments and are already familiar with TN sponsorship logistics. Narrowing your search to FDA-regulated sectors shortens the time from offer to TN approval.
Request a detailed offer letter from your employer
CBP officers assess TN eligibility on the spot using your offer letter. For a Senior Director role, the letter must specify regulatory strategy responsibilities, your qualifying degree, and that the position is temporary in nature. Vague letters stall or derail same-day approvals.
Use Migrate Mate to find TN-ready employers
Search Migrate Mate to identify companies actively posting Senior Director Regulatory Affairs roles with TN visa sponsorship. Filtering by sponsorship type upfront saves you from pursuing employers unfamiliar with TN requirements for director-level regulatory positions.
Clarify dual-intent limitations before accepting an offer
TN status does not allow dual intent, meaning concurrent pursuit of a green card can jeopardize renewals. If an employer's long-term retention plan involves EB-1 or EB-2 sponsorship, discuss immigration sequencing with an attorney before signing an offer at the director level.
Prepare for USCIS scrutiny on Mexican applications
Mexican nationals apply for TN visas at a U.S. consulate and face a formal visa interview. Bring your degree transcripts, a credential evaluation if your institution is outside North America, and the employer offer letter, since consular officers verify specialty occupation qualifications more formally than CBP does at land ports.
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Find Senior Director Regulatory Affairs JobsSenior Director Regulatory Affairs TN Visa: Frequently Asked Questions
Does a Senior Director Regulatory Affairs role qualify for TN visa sponsorship?
Yes, if your degree is in a qualifying field such as chemistry, biology, pharmacy, or a related life science, and the role involves regulatory strategy and compliance within an FDA-regulated environment. CBP evaluates TN eligibility based on the direct relationship between your academic credentials and the specific duties described in the offer letter.
How does TN compare to H-1B for this role?
TN has no annual lottery and no cap for Canadian citizens, so you can start as soon as an employer extends an offer and the paperwork clears. H-1B requires entering a randomized lottery each spring with a selection rate well below 50 percent. For Senior Director Regulatory Affairs candidates with a qualifying degree, TN is faster and more predictable than H-1B in almost every scenario.
Where can I find Senior Director Regulatory Affairs jobs that offer TN visa sponsorship?
Migrate Mate is built specifically for TN visa job seekers and filters listings by sponsorship type, so you can focus on employers already open to TN candidates. Searching a general job board and then individually asking each employer about TN familiarity is a slower and less reliable approach for a director-level regulatory role.
Can a Senior Director Regulatory Affairs position be renewed on TN status indefinitely?
TN status is granted in increments of up to three years and can be renewed without a statutory limit, provided the position remains temporary in nature and your employer continues to sponsor the role. USCIS or CBP officers may scrutinize renewals at senior levels if the permanency of the position is not clearly addressed in supporting documentation.
What happens to my TN status if I change employers in this role?
TN status is employer-specific. If you accept a Senior Director Regulatory Affairs position with a new company, that employer must file a new TN petition with USCIS or you must reapply at a port of entry before you begin work. Canadians can often complete this at the border with the new offer letter and supporting credentials in hand.
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