Director, Regulatory Advertising and Promotion

Bayer•Hanover Township, NJ

1d•Onsite

About The Position

The Director, Regulatory Advertising and Promotion is responsible for providing strategic regulatory leadership to ensure advertising and promotional activities for Bayer’s pharmaceutical portfolio are fully compliant with US regulations, FDA guidance, PhRMA guidelines, and internal policies. In this role, you support the ethical and compliant commercialization of pharmaceutical products by shaping proactive regulatory strategies, driving regulatory intelligence, and engaging effectively with internal stakeholders and regulatory authorities to enable impactful, patient-focused promotion that aligns with Bayer’s business objectives and values.

Requirements

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.

Nice To Haves

Advanced scientific degree (PhD, MD, DVM, or PharmD) with at least 8 years of industry experience, or MS with 10 years, or BS with 14 years of relevant industry experience.
Minimum of 5 years of regulatory experience in a highly regulated prescription drug environment.
Knowledge of radiology contrast media agents and their regulatory and promotional considerations.

Responsibilities

Provide strategic regulatory advice on advertising and promotional materials for assigned products, aligning promotional concepts with US regulatory requirements and Bayer’s business objectives.
Serve as the primary Regulatory Advertising & Promotion representative on Promotional Review Teams (PRTs) and lead the regulatory aspects of the Legal, Medical, and Regulatory review and approval process to ensure compliant, high-quality materials.
Manage post-marketing promotional submissions and all communications with FDA’s Office of Prescription Drug Promotion (OPDP), including 2253 and time-of-first-use submissions, and support pre-clearance submissions as needed.
Develop and execute forward-looking regulatory strategies that enable commercially viable marketing while maintaining full regulatory and ethical compliance, ensuring promotional materials accurately reflect current US Prescribing Information and labeling changes.
Monitor, interpret, and communicate emerging FDA regulations, guidance, enforcement actions, and industry trends impacting promotion and advertising, translating insights into clear, actionable guidance for internal stakeholders.
Provide regulatory input to Global Project Teams to support development of US labeling suitable for future promotional activities and support FDA meetings, labeling negotiations, and regulatory interactions related to advertising and promotion.
Maintain awareness of competitor promotional activities through attendance at major medical and industry meetings and prepare OPDP complaint letters when required, in alignment with Bayer standards and strategic considerations.
Provide training, guidance, and day-to-day support to internal stakeholders and Bayer representatives involved in promotional and exhibit activities, fostering strong cross-functional collaboration with Legal, Medical, Marketing, Regulatory, and other allied functions.
Establish and maintain a professional, constructive working relationship with FDA OPDP/APLB and mentor, coach, and support the development of Regulatory Advertising & Promotion colleagues to build a high-performing, future-ready team.