Director Advertising & Promotions, Regulatory Affairs - Bayer Corporation

At Bayer we’re visionaries, driven to solve the world’s toughest challenges and striving for a world where 'Health for all Hunger for none’ is no longer a dream, but a real possibility. We’re 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 you’re hungry to build a varied and meaningful career in a community of brilliant and diverse minds to make a real difference, there’s only one choice.

Director Advertising & Promotions, Regulatory Affairs  

The Director Advertising & Promotion, Regulatory Affairs provides strategic regulatory advice, risk assessment, and mitigation strategies to support the advertising and promotion of assigned products in accordance with business goals and objectives, FDA regulations/guidances, PhRMA guidelines and company policy.

Serves as a primary regulatory advertising and promotion reviewer for assigned products on Legal/Medical/Regulatory ("PRT") teams.

OUR TASKS AND RESPONSIBILITIES

The primary responsibilities of this role, Director Advertising & Promotion, Regulatory Affairs are to:

• Provide leadership for and manage regulatory aspects of the LMR review / approval process for product promotional materials, maintain compliance of promotional materials with the governing FDA regulations, and submit promotional materials to OPDP in a timely fashion;
• Provide risk assessment and mitigation strategies for maximizing the commercial aspects for the marketing of assigned products while ensuring compliance with FDA promotional regulations;
• Advise the Corporation on relevant new and existing regulatory risk and compliance requirements and provide regulatory expertise, advice, and support to Sales & Marketing and other product-related teams and the Legal Medical Regulatory team (LMR). Foster and facilitate teamwork between RA and these allied functions;
• Stay abreast of innovation channels and work with business to understand how regulations can apply to new marketing tactics;

• Foster collaborative, efficient, and effective working relations with FDA in order to further build the cordial working relationship between Bayer and FDA;

• Monitor and interpret promotional labeling regulations and guidelines for the successful and compliant commercial marketing of Bayer’s pharmaceutical products. Pro-actively monitor the latest regulations, guidances, and actions from the FDA and competitors that may influence the landscape. Provide colleagues in RA and allied functions with cutting edge guidance on requirements and changes;
• Contribute to the development and implementation of Corporate and Department procedures and policies for regulation of marketed promotional materials;
• Strategize cross-functionally in product labeling negotiations to optimize language and enable commercial to create impactful promotional claims;
• Provide recommendations to the RA strategists on Global Project Teams to ensure that regulatory strategy will result in commercially viable US labeling upon which future promotion and advertising will be based (Target Product Profile);

• Mentor Regulatory Advertising personnel.

WHO YOU ARE

Bayer seeks an incumbent who possesses the following:

Required Qualifications:

• Bachelor of Science degree with extensive Pharmaceutical industry experience;
• Experience in understanding the regulations and applying them to innovative channels to help move the organization forward;
• Expert knowledge of US regulations for drug promotion/advertising and US labeling required;
• Experience in the regulatory review of drug advertising and promotion required;
• Proven ability to analyze and interpret efficacy and safety data;
• Strong understanding of business goals of the involved business franchise, marketing concepts and tools required;
• Must perform independently with strong negotiation and decision making skills;
• Must be able to work in a multi-disciplinary environment;.
• Must possess strong interpersonal and communication skills;
• Must have analytical and problem-solving skills associated with problem reviews and inquiries;
• Must be able to provide creative solutions to complex problems.

Preferred Qualifications:

• Advanced technical degree (Ph.D., M.D., D.V.M. or Pharm.D. in life sciences with minimum of 8 years Pharmaceutical industry experience or MS degree with minimum 10 years Pharmaceutical industry experience.

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