The Associate Director, Global Regulatory Affairs, Advertising and Promotion lead will act as the Subject Matter Expert for assigned products and projects focusing on advertising and promotion regulatory affairs. They will provide regulatory guidance during development, review, approval, and implementation of medical and commercial materials. They will also lead the Commercial Material Review Process (CMRP) and be responsible for strategic business partnerships, regulatory compliance, and patient safety.
Requirements
- BSc Degree, preferred. BA accepted.
- 8+ years of pharmaceutical industry experience
- 6 years of regulatory experience or combination of 5+ years regulatory and/or related experience
- Ability to understand ABPI, EFPIA and other international code and guidance about advertising and promotion for prescription medicines
- Experience in prescription medicine promotion development and review process
- Strong interpersonal skills with ability to demonstrate strategic and analytic thinking
- Demonstrated ability to communicate clearly and concisely
- Highly effective written and verbal communication skills to manage, motivate and drive decisions within teams
- Proven skills in negotiation, influencing without authority and working diplomatically through conflict
- Demonstrated cross-functional people management with a desire to foster a positive team culture
- Ability to work independently, take initiative and complete tasks to deadlines
- Previous experience in an advertising and promotion role
- Proven experience and expertise in regulatory affairs, particularly advertising and promotion, with familiarity in EFPIA, IFPMA, and FDA standards
- Strong leadership, negotiation, and conflict resolution skills within cross-functional teams
- Strategic mindset and ability to assess and advise regulatory impacts across the product lifecycle
- Adept in guiding teams through complex advertising and promotion processes with a focus on patient safety and compliance
Benefits
- Generous Paid Time Off
- 401k Matching
- Retirement Plan
- Visa Sponsorship
- Four Day Work Week
- Generous Parental Leave
- Tuition Reimbursement
- Relocation Assistance