Director, Regulatory Advertising and Promotion
$169,680–$254,520 year
On-site · Whippany, New Jersey, United States
Job Summary
Director, Regulatory Advertising and Promotion role responsible for providing strategic regulatory leadership to ensure Bayer’s advertising and promotional activities for the pharmaceutical portfolio comply with US regulations, FDA guidance, PhRMA guidelines, and internal policies. Lead regulatory aspects of Promotional Review Teams (PRTs), manage OPDP submissions (2253 and pre-clearance), develop forward‐looking regulatory strategies, monitor FDA regulations and industry trends, provide regulatory input to Global Project Teams for US labeling, train and mentor internal stakeholders, and maintain relationships with FDA OPDP/APLB while fostering cross‐functional collaboration to enable compliant, patient‐focused promotion.
Required Qualifications
- Extensive knowledge of US FDA regulations and guidance for prescription drug advertising, promotion, and labeling, with demonstrated experience reviewing professional and consumer promotional materials
- Proven experience leading OPDP promotional submissions, including 2253 and pre‐clearance submissions, and supporting product launches from a regulatory advertising and promotion perspective
- Strong ability to critically analyze and interpret clinical efficacy and safety data and to integrate scientific, medical, and regulatory considerations into promotional strategies
- Solid understanding of commercial strategy, marketing concepts, and business objectives, with the ability to balance regulatory risk and business needs
- Strong independent judgment, decision‐making, and negotiation skills, with the ability to provide creative and pragmatic solutions to complex regulatory challenges
- Ability to work effectively in a highly collaborative, cross‐functional environment, demonstrating excellent written, verbal, and interpersonal communication skills and strong analytical and problem‐solving capabilities
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