Associate Director / Director, Regulatory Advertising and Promotion

Associate Director/Director, Regulatory Advertising & Promotion Responsibilities Serve as Ad Promo regulatory lead for assigned products (commercial and/or pipeline).
Provide proactive guidance on promotional strategy, claims development, and risk positioning.
Partner with Commercial, Medical, Legal, and Clinical to align messaging with labeling and data.
Interpret and apply FDA regulations, OPDP guidance/enforcement trends, and industry standards.
Assess regulatory risk and recommend mitigation strategies.
Lead review/approval of promotional materials through the MLR committee.
Ensure materials are accurate, balanced, and supported by substantial evidence.
Provide strategic direction for disease awareness, HCP/patient materials, digital content, and launch campaigns; support advisory boards/speaker programs/field training.
Partner with Regulatory Labeling to ensure claims align with approved labeling and clinical data; anticipate labeling implications.
Monitor FDA enforcement actions and emerging trends; support OPDP/regulatory inquiries and inspection-readiness activities.
Required Advanced scientific degree (PharmD, PhD, MD) or equivalent.
8+ years pharmaceutical experience with 5+ years+ relevant ad promo experience.
Deep understanding of FDA promotional regulations and OPDP expectations.
Experience supporting commercial launches and/or late-stage development.
Ability to influence cross-functional stakeholders in a matrixed environment.
Preferred Experience in rare disease or specialty therapeutics.
Where you’ll work Onsite at San Francisco office.
Benefits Market-leading compensation; 401(k) employer match; ESPP; pre-tax commuter benefits; paid parental leave; hybrid model; unlimited PTO; subsidized lunch; comprehensive health care premiums covered.

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