Reg Affairs Director
Ladders · United States · 5 days ago
RemoteRemoteOTHR$230k–$285k/yrFull-time
Responsibilities
- Serve as the Ad Promo regulatory lead for assigned products
- Provide proactive guidance on promotional strategy and claims development
- Partner with cross-functional teams to align messaging with labeling
- Interpret FDA regulations and industry standards for business initiatives
- Lead the review and approval of promotional materials through MLR processes
- Provide strategic direction on disease awareness and launch campaigns
- Monitor FDA enforcement actions and support inspection readiness
Qualifications
- Advanced scientific degree (PharmD, PhD, MD) or equivalent
- 8+ years of pharmaceutical experience with 5+ years in advertising and promotion
- Deep understanding of FDA promotional regulations and OPDP expectations
- Experience supporting commercial launches or late-stage development programs
- Demonstrated ability to influence stakeholders in a matrixed environment
Benefits
- Market-leading compensation
- 401(k) with employer match
- 100% employer-paid medical, dental, and vision premiums for you and your dependents
- Flexible, 'take-what-you-need' paid time off and company-paid holidays
- Hybrid work model with flexibility