AD Promo Reviewer Regulatory Affairs
Newark Metro Area, NJ
Responsibilities will include, but are not limited to, the following:
Supports interactions with the Food and Drug Administration (FDA) Office of Prescription Drug Promotion (OPDP) for assigned product(s).
With oversight from Director level or above, develop regulatory strategies and provide guidance to other departments.
Manage timelines and resources to achieve stated goals.
Foster and facilitate teamwork between regulatory, legal, medical and commercial colleagues participating the Promotional Review (PACT) process.
Assess regulatory risk and develop mitigation strategies with oversight.
Provide regulatory advice and support to commercial teams and (PACT), with oversight.
Develop departmental guidance and procedures.
Manage regulatory aspects of the copy review / approval process for product promotional materials for assigned products, indications, or audiences. Ensure compliance of promotional materials with the governing FDA regulations, and ensure submission of promotional materials to OPDP in a timely fashion.
Design and conduct departmental training
Monitor and interpret promotional labeling regulations and guidelines for the successful and compliant commercial marketing of company s pharmaceutical products. Pro-actively monitor the latest regulations, guidance, and actions from the FDA and competitors that may influence the landscape.
Bachelors degree (BA or BS). Scientific discipline preferred.
3-7 years of pharmaceutical industry experience, including 2-4 years in regulatory affairs.
Knowledge of FDA advertising and promotional regulations and guidance is necessary.
Must be able to innovate, analyze, and solve problems with minimal supervisory input.
Excellent communications, listening, and negotiation skills are necessary.
Leadership skills required.
Excellent organizational and time management skills needed to manage multiple ongoing projects simultaneously.
Must be an innovator of new ideas and best practices
Must recognize potential problems
Must have outstanding attention to detail.