Head of Regulatory Advertising and Promotion
Company: BioMarin Pharmaceutical Inc.
Location: San Rafael
Posted on: October 28, 2025
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Job Description:
Title: Regulatory Advertising and Promotion, Director SUMMARY
The Director of Regulatory Advertising and Promotion is a strategic
role leading the development and management of 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 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
Director will also be responsible for building and managing the
Regulatory Advertising and Promotion group to ensure regulatory and
strategic support for current and future BioMarin products. This
position will be responsible for: RESPONSIBILITIES Lead the
Regulatory Advertising and Promotion group and ensure high
functioning personnel are deployed to the Promotional Review Boards
(PRB) for BioMarin products. 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 Required Skills:
A minimum of 8 years required of regulatory experience and
extensive experience (at least 5 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 Desired Skills: • Expertise in
US labeling requirements and legal and compliance considerations
for FDA-regulated drugs • Biologics and rare disease experience is
desirable. EDUCATION Minimum requirements Science based BS or MS or
business or legal degree with extensive regulatory experience.
Advanced scientific or legal degree desirable but not required.
SUPERVISOR RESPONSIBILITY This position will have direct report(s).
Position is based in the US and can be remote. Some periodic to
travel to BioMarin offices in the US and other locations as needed
to support business needs.
Keywords: BioMarin Pharmaceutical Inc., San Rafael , Head of Regulatory Advertising and Promotion, Legal , San Rafael, California
