Head of Regulatory Advertising and Promotion

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 :

Desired Skills :

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 travel to BioMarin offices in the US and other locations as needed to support business needs.

The salary range for this position is : $177,800 to $266,800. BioMarin considers a variety of factors when determining base compensation, including experience, qualifications, and geographic location. These considerations mean actual compensation will vary. This position may also be eligible for a discretionary annual bonus, discretionary stock-based long-term incentives (eligibility may vary based on role), paid time off, and a benefits package. Benefits include company-sponsored medical, dental, vision, and life insurance plans.

For additional benefits information, visit the BioMarin careers website.

Eligible employees may participate in benefit plans, subject to the terms and conditions of the applicable plans.

#J-18808-Ljbffr