H-1B Visa Senior Director Regulatory Affairs Jobs
Senior Director Regulatory Affairs roles qualify as H-1B visa 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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Immunome is a clinical-stage targeted oncology company committed to developing first-in-class and best-in-class targeted cancer therapies. We are advancing an innovative portfolio of therapeutics, supported by a leadership team with deep experience in the design, development, and commercialization of cutting-edge therapies, including antibody-drug conjugates. Our pipeline includes varegacestat, an investigational gamma secretase inhibitor for which an NDA has been submitted to the U.S. FDA; IM-1021, a clinical-stage ROR1 ADC; IM-3050, an IND-cleared FAP-targeted radiotherapy; and IM-1617, an IND-cleared solid tumor ADC. We are also advancing a broad portfolio of early-stage ADCs pursuing undisclosed solid tumor targets.
Position Overview
Immunome is seeking a highly experienced and strategic Director / Senior Director, Regulatory Affairs Advertising & Promotion to provide regulatory leadership for U.S. advertising, promotional labeling, and medical communications across our oncology portfolio. This role will partner with Commercial, Medical Affairs, Legal, and Compliance to enable compliant and competitive communication strategies from early launch planning through post-launch execution. The successful candidate will bring deep expertise in FDA advertising and promotion regulations and OPDP practices, strong judgment and risk-based decision making, and proven leadership in medical-legal-regulatory review environments. This position offers an opportunity to build Immunome’s Advertising & Promotion capabilities as we prepare for and execute commercial launches.
Responsibilities
Strategic Leadership
- Develop and execute the U.S. regulatory Advertising & Promotion (A&P) strategy across the product lifecycle, from pre-launch planning through post-market execution.
- Provide strategic guidance on promotional positioning, claims, and evidence requirements in alignment with approved labeling, clinical data, and internal standards.
- Serve as the internal subject matter expert on FDA advertising and promotion regulations and guidance, including awareness of OPDP enforcement trends and best practices.
Promotional Review and Risk Management
- Serve as the regulatory lead for Immunome’s Medical-Legal-Regulatory (MLR) committee to ensure consistent, timely, and compliant review of materials.
- Review and approve promotional labeling, advertising, and external communications (HCP and consumer, digital/social, congress, speaker programs, sales training, and other materials as applicable) for compliance with regulations, guidance, and company SOPs.
- Drive risk identification and mitigation plans; document regulatory rationale and provide clear, practical feedback to cross-functional stakeholders and agency partners.
Regulatory Submissions and Agency Interactions
- Oversee preparation, quality control, and timely submission of promotional materials (e.g., FDA Form 2253 submissions) and maintain submission tracking, records, and archives.
- Lead or support OPDP interactions related to promotional materials, advisory comments, requests for information, and response development in collaboration with Regulatory leadership and Legal.
Policy, Training, and Compliance
- Establish, maintain, and continuously improve A&P policies, SOPs, templates, and review standards to increase consistency and efficiency.
- Develop and deliver training for cross-functional teams and vendors on promotional regulations, scientific exchange, and compliant communications.
- Monitor FDA guidance, industry trends, and enforcement actions to proactively update internal standards and advise leadership on emerging risks and opportunities.
Leadership and Collaboration
- Build and mentor a high-performing A&P team; set clear objectives, provide coaching, and foster a culture of collaboration and accountability.
- Act as a strategic partner to Commercial, Medical Affairs, Market Access, and Patient Advocacy teams to enable effective, compliant communication strategies.
- Manage external agencies and vendors supporting promotional development, ensuring alignment with regulatory strategy, submission requirements, and compliance expectations.
Qualifications
- Pharm.D., Ph.D., M.S., or other advanced degree in life sciences or related field; B.S. with commensurate experience will be considered.
- A minimum of 10+ years of Regulatory Affairs experience in the biopharmaceutical industry with significant focus on U.S. advertising and promotion (A&P) review experience in oncology with product launch experience, or equivalent.
- Demonstrated experience leading regulatory review of promotional materials in a MLR environment, including omnichannel and digital/social communications.
- Strong knowledge of FDA advertising and promotion regulations, promotional submission requirements (e.g., FDA Form 2253), Subpart E/H, and other related regulatory activities, as applicable.
- Proven track record supporting product launches and lifecycle management, including pre-approval communications and early commercialization planning.
- Experience interacting with OPDP and managing responses to regulatory comments, advisory feedback, or enforcement actions.
- Experience in a fast-paced, growth-stage biotech environment strongly preferred.
Knowledge And Skills
- In-depth knowledge of U.S. promotional regulations, FDA/OPDP guidance, and current enforcement trends. Experience in oncology is a plus.
- Strong ability to translate scientific and clinical data into compliant claims and messaging frameworks; excellent judgment in risk-benefit assessment.
- Proven leadership and influence skills with the ability to drive timely decisions and alignment across cross-functional stakeholders.
- Excellent written and verbal communication skills, including the ability to provide clear, actionable feedback to teams and agencies.
- Demonstrated success developing, implementing, and improving A&P processes, SOPs, and training programs.
- Highly organized with strong project management skills and the ability to manage multiple products and competing priorities.
- Collaborative, solutions-oriented mindset with strong stakeholder management and conflict resolution skills.
- Experience managing and developing staff and external vendors/partners.
Location
This role may be performed either onsite at our Bothell, WA location or remotely within the U.S.
Washington State Pay Range
$222,933 - $310,500 USD
E/E/O
Immunome, Inc. is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.
E-Verify
Immunome, Inc. is a participant in E-Verify. Please review the following notices: E-Verify Participation Poster | Right to Work Poster (English) | Right to Work Poster (Spanish).
Company Overview
Immunome is a clinical-stage targeted oncology company committed to developing first-in-class and best-in-class targeted cancer therapies. We are advancing an innovative portfolio of therapeutics, supported by a leadership team with deep experience in the design, development, and commercialization of cutting-edge therapies, including antibody-drug conjugates. Our pipeline includes varegacestat, an investigational gamma secretase inhibitor for which an NDA has been submitted to the U.S. FDA; IM-1021, a clinical-stage ROR1 ADC; IM-3050, an IND-cleared FAP-targeted radiotherapy; and IM-1617, an IND-cleared solid tumor ADC. We are also advancing a broad portfolio of early-stage ADCs pursuing undisclosed solid tumor targets.
Position Overview
Immunome is seeking a highly experienced and strategic Director / Senior Director, Regulatory Affairs Advertising & Promotion to provide regulatory leadership for U.S. advertising, promotional labeling, and medical communications across our oncology portfolio. This role will partner with Commercial, Medical Affairs, Legal, and Compliance to enable compliant and competitive communication strategies from early launch planning through post-launch execution. The successful candidate will bring deep expertise in FDA advertising and promotion regulations and OPDP practices, strong judgment and risk-based decision making, and proven leadership in medical-legal-regulatory review environments. This position offers an opportunity to build Immunome’s Advertising & Promotion capabilities as we prepare for and execute commercial launches.
Responsibilities
Strategic Leadership
- Develop and execute the U.S. regulatory Advertising & Promotion (A&P) strategy across the product lifecycle, from pre-launch planning through post-market execution.
- Provide strategic guidance on promotional positioning, claims, and evidence requirements in alignment with approved labeling, clinical data, and internal standards.
- Serve as the internal subject matter expert on FDA advertising and promotion regulations and guidance, including awareness of OPDP enforcement trends and best practices.
Promotional Review and Risk Management
- Serve as the regulatory lead for Immunome’s Medical-Legal-Regulatory (MLR) committee to ensure consistent, timely, and compliant review of materials.
- Review and approve promotional labeling, advertising, and external communications (HCP and consumer, digital/social, congress, speaker programs, sales training, and other materials as applicable) for compliance with regulations, guidance, and company SOPs.
- Drive risk identification and mitigation plans; document regulatory rationale and provide clear, practical feedback to cross-functional stakeholders and agency partners.
Regulatory Submissions and Agency Interactions
- Oversee preparation, quality control, and timely submission of promotional materials (e.g., FDA Form 2253 submissions) and maintain submission tracking, records, and archives.
- Lead or support OPDP interactions related to promotional materials, advisory comments, requests for information, and response development in collaboration with Regulatory leadership and Legal.
Policy, Training, and Compliance
- Establish, maintain, and continuously improve A&P policies, SOPs, templates, and review standards to increase consistency and efficiency.
- Develop and deliver training for cross-functional teams and vendors on promotional regulations, scientific exchange, and compliant communications.
- Monitor FDA guidance, industry trends, and enforcement actions to proactively update internal standards and advise leadership on emerging risks and opportunities.
Leadership and Collaboration
- Build and mentor a high-performing A&P team; set clear objectives, provide coaching, and foster a culture of collaboration and accountability.
- Act as a strategic partner to Commercial, Medical Affairs, Market Access, and Patient Advocacy teams to enable effective, compliant communication strategies.
- Manage external agencies and vendors supporting promotional development, ensuring alignment with regulatory strategy, submission requirements, and compliance expectations.
Qualifications
- Pharm.D., Ph.D., M.S., or other advanced degree in life sciences or related field; B.S. with commensurate experience will be considered.
- A minimum of 10+ years of Regulatory Affairs experience in the biopharmaceutical industry with significant focus on U.S. advertising and promotion (A&P) review experience in oncology with product launch experience, or equivalent.
- Demonstrated experience leading regulatory review of promotional materials in a MLR environment, including omnichannel and digital/social communications.
- Strong knowledge of FDA advertising and promotion regulations, promotional submission requirements (e.g., FDA Form 2253), Subpart E/H, and other related regulatory activities, as applicable.
- Proven track record supporting product launches and lifecycle management, including pre-approval communications and early commercialization planning.
- Experience interacting with OPDP and managing responses to regulatory comments, advisory feedback, or enforcement actions.
- Experience in a fast-paced, growth-stage biotech environment strongly preferred.
Knowledge And Skills
- In-depth knowledge of U.S. promotional regulations, FDA/OPDP guidance, and current enforcement trends. Experience in oncology is a plus.
- Strong ability to translate scientific and clinical data into compliant claims and messaging frameworks; excellent judgment in risk-benefit assessment.
- Proven leadership and influence skills with the ability to drive timely decisions and alignment across cross-functional stakeholders.
- Excellent written and verbal communication skills, including the ability to provide clear, actionable feedback to teams and agencies.
- Demonstrated success developing, implementing, and improving A&P processes, SOPs, and training programs.
- Highly organized with strong project management skills and the ability to manage multiple products and competing priorities.
- Collaborative, solutions-oriented mindset with strong stakeholder management and conflict resolution skills.
- Experience managing and developing staff and external vendors/partners.
Location
This role may be performed either onsite at our Bothell, WA location or remotely within the U.S.
Washington State Pay Range
$222,933 - $310,500 USD
E/E/O
Immunome, Inc. is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.
E-Verify
Immunome, Inc. is a participant in E-Verify. Please review the following notices: E-Verify Participation Poster | Right to Work Poster (English) | Right to Work Poster (Spanish).
See all H-1B Visa Senior Director Regulatory Affairs Jobs
Sign up for free to unlock all listings, filter by visa type, and get alerts for new H-1B Visa Senior Director Regulatory Affairs Jobs.
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.
H-1B Visa Senior Director Regulatory Affairs: 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.