Description

Who We Are

BioMarin 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.

• 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 BioMarin’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 BioMarin 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.  

• Experience negotiating with internal and external stakeholders on complex regulatory issues of importance to BioMarin
• Seasoned regulatory professional with experience in submissions for products in development and commercial products
• Experience in leading activities for OPDP submissions, including time of first use submissions, requests for advisory comments, and 30-day submissions for accelerated approval products 
• Outstanding interpersonal and communication (written and verbal) skills
• Must have full working experience in MS Word, PowerPoint, Excel, document management systems (e., Veeva) and regulatory information management systems a plus  
• Excellent writing and communication skills
• Must have strong negotiation skills, extensive experience in cross functional collaboration, and independent decision making skills
• Proven analytic ability and problem solving skills
• Extensive knowledge of FDA evidence standards for prescription drug labeling and promotion and ability to analyze efficacy, safety and other scientific data and evidence

• Expertise in US labeling requirements and legal and compliance considerations for FDA-regulated drugs
• Biologics and rare disease experience is desirable.

Note: This description is not intended to be all-inclusive, or a limitation of the duties of the position. It is intended to describe the general nature of the job that may include other duties as assumed or assigned.

Equal Opportunity Employer/Veterans/Disabled

An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.