Director, Regulatory Advertising and Promotion

At Bayer were visionaries driven to solve the worlds toughest challenges and striving for a world where Health for all Hunger for none is no longer a dream but a real possibility. Were doing it with energy curiosity and sheer dedication always learning from unique perspectives of those around us expanding our thinking growing our capabilities and redefining impossible. There are so many reasons to join us. If youre hungry to build a varied and meaningful career in a community of brilliant and diverse minds to make a real difference theres only one choice.

Director Regulatory Advertising and Promotion

PURPOSE

The Director Regulatory Advertising and Promotion is responsible for providing strategic regulatory leadership to ensure your advertising and promotional activities for Bayers 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 patientfocused promotion that aligns with Bayers business objectives and values.

YOUR TASKS AND RESPONSIBILITIES

The primary responsibilities of this role Director Regulatory Advertising and Promotion are to:

• Provide strategic regulatory advice on advertising and promotional materials for assigned products aligning promotional concepts with US regulatory requirements and Bayers 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 highquality materials;
• Manage postmarketing promotional submissions and all communications with FDAs Office of Prescription Drug Promotion (OPDP) including 2253 and timeoffirstuse submissions and support preclearance submissions as needed;
• Develop and execute forwardlooking 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 daytoday support to internal stakeholders and Bayer representatives involved in promotional and exhibit activities fostering strong crossfunctional 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 highperforming futureready team.

WHO YOU ARE

Bayer seeks an incumbent who possesses the following:

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 preclearance 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 decisionmaking and negotiation skills with the ability to provide creative and pragmatic solutions to complex regulatory challenges;
• Ability to work effectively in a highly collaborative crossfunctional environment demonstrating excellent written verbal and interpersonal communication skills and strong analytical and problemsolving capabilities.

Preferred Qualifications:

• 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.

Employees can expect to be paid a salary between $169680.00 - $254520.00.Additional compensation may include a bonus or commission (if relevant). Additional benefits include health care vision dental retirement PTO sick leave etc.

This salary range is merely an estimate and may vary based on an applicants location market data/ranges an applicants skills and prior relevant experience certain degrees and certifications and other relevant factors.

This posting will be available for application until at least 5/27/26.

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