Key Result Areas (major Duties, Accountabilities And Responsibilities)
- Leads regulatory review and approval for promotional, medical education and corporate materials for regulatory compliance.
- Applies regulatory and therapeutic area knowledge to develop solutions to complex US promotional issues; ensures global regulatory compliance and manages business risks.
- Monitors competitive activities by tracking major US medical congresses.
- Monitors the US regulatory promotional environment by reviewing promotional guidance, untitled/warning letters, and attending FDLI, DIA and other industry/FDA meetings.
- Presents shared learnings to senior management and cross-functional teams from FDA advisory comments, enforcement actions and guidance.
- Primary liaison with FDA’s APLB (advisory comments, voluntary submissions, responses to inquiries); ensures submissions via 2253.
- Ensures changes in US Prescribing Information are reflected in promotions/advertising.
- Provides input on metrics to measure/track promotional review effectiveness/efficiency and recommends process improvements.
- Works independently; escalates risks to senior leadership when appropriate.
Qualifications & Skills
- Degree in life science or equivalent; advanced degree (PharmD, PhD, MS, JD) preferred.
- 12+ years Regulatory Affairs promotion/advertising experience with prescription drug/biologic products.
- Deep expertise in FDA Ad/Promo landscape.
- Solution-oriented negotiator; experience with rare disease essential; gene therapy strongly preferred.
- Independent regulatory review experience in biotech/pharma.
- APLB submission leadership experience (incl. first-use submissions, advisory comment requests, and Subpart H 30-day submissions).
- Knowledge of US regulations for drug promotion/advertising and US labeling; evaluates regulatory risk and communicates clearly to MLR and cross-functional partners.
- Leadership in highly matrixed environments; team management; understands franchise business goals/marketing tools.
- Ability to analyze efficacy and safety data; excellent communication and project timeline management.
- Launch readiness planning/execution; prior Veeva PromoMats and RIM experience.
- Track record overseeing non-US FDA regulatory requirements (EMA, MHRA, Health Canada, PMDA).
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