Associate Director / Director, Regulatory Advertising and Promotion
BridgeBio
8 days ago
On-site
Washington, DC
Marketing
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 (as stated)
- 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.
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 (as stated)
- 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.