Director, US Regulatory Affairs, Advertising & Promotion
Cytokinetics
September 02, 2026
Remote friendly (San Francisco Bay Area)
United States
Corporate Functions
Director Regulatory Affairs, Advertising and Promotion
Responsibilities
- Lead regulatory review and approval of U.S. product promotional materials.
- Ensure product claims are supported by FDA-approved labeling and are scientifically substantiated.
- Serve as regulatory advertising and promotion subject matter expert.
- Provide strategic regulatory guidance to influence cross-functional decision-making.
- Mentor junior regulatory professionals; lead continuous improvement of promotional review processes and governance.
- Represent Regulatory on the MLR Committee; provide input during new concept reviews; review/approve materials for regulatory compliance.
- Review non-promotional assets (medical, corporate affairs, market access/payor communications, patient advocacy materials).
- Develop and update Important Safety Information (ISI) and risk presentations for commercial assets.
FDA Liaison & Submissions
- Lead regulatory strategy for OPDP interactions (advisory comments, enforcement responses, and correspondence).
- Manage FDA Form 2253 submissions for applicable commercial assets.
- Lead voluntary advisory comment submissions for identified materials.
Corporate Readiness & Training
- Monitor OPDP enforcement trends and FDA guidance; communicate updates with stakeholders.
- Create/update SOPs or work instructions to optimize processes.
- Train U.S. marketing, sales, and medical affairs teams on regulatory compliance.
Qualifications
- Education: Required: Bachelor’s degree; Preferred: PharmD, PhD, or JD.
- Experience: Minimum 10 years in pharmaceutical/biotechnology regulatory affairs; at least 7 years in U.S. advertising and promotion; successful drug/biologic launches; direct history managing OPDP interactions/submissions.
- Skills: Expert knowledge of FDA biologics promotional compliance; Veeva Vault PromoMats; ability to interpret complex clinical data into compliant marketing messages; strong written/verbal skills; cross-functional collaboration.
Compensation/Benefits
- Expected salary range (South San Francisco, CA): $225,000-$262,500; includes equity and comprehensive benefits (health/dental/vision/life/disability, 401k match, learning/wellness stipends, paid time off).
Application instructions
- Please review the GDPR policy prior to applying.
Responsibilities
- Lead regulatory review and approval of U.S. product promotional materials.
- Ensure product claims are supported by FDA-approved labeling and are scientifically substantiated.
- Serve as regulatory advertising and promotion subject matter expert.
- Provide strategic regulatory guidance to influence cross-functional decision-making.
- Mentor junior regulatory professionals; lead continuous improvement of promotional review processes and governance.
- Represent Regulatory on the MLR Committee; provide input during new concept reviews; review/approve materials for regulatory compliance.
- Review non-promotional assets (medical, corporate affairs, market access/payor communications, patient advocacy materials).
- Develop and update Important Safety Information (ISI) and risk presentations for commercial assets.
FDA Liaison & Submissions
- Lead regulatory strategy for OPDP interactions (advisory comments, enforcement responses, and correspondence).
- Manage FDA Form 2253 submissions for applicable commercial assets.
- Lead voluntary advisory comment submissions for identified materials.
Corporate Readiness & Training
- Monitor OPDP enforcement trends and FDA guidance; communicate updates with stakeholders.
- Create/update SOPs or work instructions to optimize processes.
- Train U.S. marketing, sales, and medical affairs teams on regulatory compliance.
Qualifications
- Education: Required: Bachelor’s degree; Preferred: PharmD, PhD, or JD.
- Experience: Minimum 10 years in pharmaceutical/biotechnology regulatory affairs; at least 7 years in U.S. advertising and promotion; successful drug/biologic launches; direct history managing OPDP interactions/submissions.
- Skills: Expert knowledge of FDA biologics promotional compliance; Veeva Vault PromoMats; ability to interpret complex clinical data into compliant marketing messages; strong written/verbal skills; cross-functional collaboration.
Compensation/Benefits
- Expected salary range (South San Francisco, CA): $225,000-$262,500; includes equity and comprehensive benefits (health/dental/vision/life/disability, 401k match, learning/wellness stipends, paid time off).
Application instructions
- Please review the GDPR policy prior to applying.