Associate Director, Regulatory Advertising – Promotion
BioMarin Pharmaceutical Inc.
full-time
Posted on:
Location Type: Remote
Location: United States
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Job Level
About the role
- 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
- 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.
Requirements
- 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 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
Benefits
- Health insurance
- Flexible working arrangements
- Professional development opportunities
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
regulatory compliancepromotional reviewadvertising submissionslabeling regulationsFDA regulationsregulatory guidanceanalytical skillsproblem solvingnegotiationcross-functional collaboration
Soft skills
interpersonal skillscommunication skillsindependent decision makingstrategic adviceteam collaborationwriting skillsverbal communicationstrategic compliance adviceleadershiptraining development