Title: Regulatory Advertising and Promotion, Director

SUMMARY

The Director of Regulatory Advertising and Promotion is a strategic role leadingthe development and management of the review, approval, and submission of advertising and promotional materials and related training and internal communications. The incumbent will be responsiblefor 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

1. Lead the Regulatory Advertising and Promotion group and ensure high functioning personnel are deployed to the Promotional Review Boards (PRB) for BioMarin products.
2. Oversee standard operating procedures, policies and practices to ensure compliance with FDA advertising and promotion regulations
3. Participate in priority PRB teams as a regulatory reviewer
4. 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.
5. Provide strategic regulatory advice to labeling and development teams to ensure appropriate support for commercial strategies for BioMarin products
6. Partner with Regulatory, Labeling, Medical Affairs, Legal, and Commercial/Marketing groups to ensure timely and efficient review of all materials.
7. 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.
8. Advise and communicate strategic compliance advice to Commercial, Legal, Medical and Regulatory colleagues.
9. 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.