Associate Director, Regulatory Advertising & Promotion

Who We Are

Bio Marin is a global biotechnology company that relentlessly pursues bold science to translate genetic discoveries into new medicines that advance the future of human health.

Since our founding in 1997, we have applied our scientific expertise in understanding the underlying causes of genetic conditions to create transformative medicines, using a number of treatment modalities.

Using our unparalleled expertise in genetics and molecular biology, we develop medicines for patients with significant unmet medical need. We enlist the best of the best - people with the right technical expertise and a relentless drive to solve real problems - and create an environment that empowers our teams to pursue bold, innovative science. With this distinctive approach to drug discovery, we've produced a diverse pipeline of commercial, clinical and preclinical candidates that have well-understood biology and provide an opportunity to be first-to-market or offer a substantial benefit over existing therapeutic options.

About Worldwide Research and Development

From research and discovery to post-market clinical development, our WWRD engine involves all bench and clinical research and the associated groups that support those endeavors. Our teams work on developing first-in-class and best-in-class therapeutics that provide meaningful advances to patients who live with genetic diseases.

The Associate Director of Regulatory Advertising and Promotion is a strategic role responsible for the review, approval, and submission of advertising and promotional materials and related training and internal communications. The incumbent will be responsible for overall compliance with FDA regulations relating to advertising and promotion of prescription drug and biologic products. The Associate Director will have extensive knowledge and experience with the regulatory review and approval of advertising and promotion, a thorough understanding of FDA evidence standards for promotional claims and content and format requirements.

The Associate Director will also be responsible for to ensure regulatory and strategic support for current and future Bio Marin products.

This position will be responsible for:

• Serve as lead Regulatory representative on the Promotional Review Board for prescription drugs/biologics promotional materials (commercial, disease-state, corporate).
• Independently review and approve promotional materials to ensure regulatory compliance with the current labeling, applicable regulations, guidance documents, and internal policies/best practices.
• Provide strategic regulatory guidance to cross-functional teams (Marketing, Medical Affairs, Legal, Commercial) on advertising/promotion campaigns, labeling interplay, and regulatory risk.
• Act as liaison with the U.S. Food & Drug Administration (FDA) Office of Prescription Drug Promotion (OPDP) and/or Advertising & Promotion Labeling Branch (APLB) for advertising/promotion matters, including advisory submissions, enforcement monitoring, Form 2253 filings.
• Support and implement processes/policies for advertising and promotion review (e.g., review committees, metrics, training).
• Monitor industry guidance, enforcement trends, external regulatory environment and apply to promotional review frameworks.
• Collaborate with Medical, Legal and Commercial to execute and approve key Commercial campaigns.
• Monitor evolving FDA regulations, enforcement actions, and industry best practices; translate insights into internal training and process improvements.
• Oversee standard operating procedures, policies and practices to ensure compliance with FDA advertising and promotion regulations
• Participate in priority PRB teams as a regulatory reviewer
• Communicate with FDA's Office of Prescription Drug Promotion (OPDP) and Advertising and Promotional Labeling Branch (APLB) as necessary to represent Bio Marin's interests for regulatory submissions, requests for advisory comments, management of enforcement actions, and other correspondence.
• Provide strategic regulatory advice to labeling and development teams to ensure appropriate support for commercial strategies for Bio Marin products
• Partner with Regulatory, Labeling, Medical Affairs, Legal, and Commercial/Marketing groups to ensure timely and efficient review of all materials.
• Monitor changes in federal, state and local laws and regulations that impact the U.S. Food and Drug Administration (FDA) requirements for the advertising and promotion.
• Advise and communicate strategic compliance advice to Commercial, Legal, Medical and Regulatory colleagues.
• Oversee the submission activities to ensure compliance with FDA regulations for advertising and promotional materials.

A minimum of 6 years required of regulatory experience with at least 4 years in regulatory advertising and promotion.

• Experience negotiating with internal and external stakeholders on complex regulatory issues of importance to Bio Marin
• Seasoned regulatory professional with…