Associate Director, Regulatory Affairs - Advertising and Promotion
Core
Review and approve US promotional materials for pharmaceutical/biologics products and serve as the regulatory expert for advertising and promotion.
Role type
Associate Director, Regulatory Affairs (Advertising and Promotion)
Builds
Compliant US marketing strategies and promotional programs for prescription products
Domain
Pharmaceutical/Biologics Industry, US Regulatory Affairs
Required skills
FDA Regulations, Promotional Review, Regulatory Compliance, Regulatory Strategies, Regulatory Submissions, Clinical Trials, Pharmaceutical Industry
Preferred skills
Cross-Functional Collaboration, Strategic Thinking, Negotiation, Product Development Knowledge
Technologies
eCTD
Responsibilities
Liaise with FDA OPDP/APLB divisions for complex regulatory questions and submissions; Propose compliant regulatory strategies for challenging promotional concepts; Provide regulatory consultation on US marketing strategy and promotional programs; Participate in labeling and global regulatory team meetings; Maintain awareness of evolving FDA regulations and guidance; Provide training and coaching to team members; Contribute to departmental strategic initiatives.
Seniority
Senior, hands-on IC with mentorship responsibilities