Associate Director Regulatory Ad/Promo

Title: Associate Director Regulatory Advertising & Promotion

One of the fastest growing biotech's in the industry is looking to bring on an Associate Director Regulatory Ad Promo to support the commercial regulatory strategy and provide further support for the business' continued growth.

Key Responsibilities:

• Review and approve the regulatory content of materials created for product promotion, corporate, and other non-promotional materials to assess for compliance with the applicable regulations, guidance documents, and internal policies/best practices.
• Represent the commercial regulatory perspective at the promotional review committee (PRC)
• Lead discussions in review committees, collaborating with stakeholders from Legal, Medical, and commercial teams to reach consensus on promotional materials.
• Serve as internal expert on FDA regulations, guidance and enforcement trends governing the promotion of Madrigal products.
• Assumes a leadership role in updating and advising Company stakeholders on changes in regulations, policies, and enforcement which may impact the Company's promotional activities.
• Lead interactions with the Office of Prescription Drug Promotion OPDP including response to regulatory inquiries, preparation of submissions for advisory comments, and timely preparation and submission of promotional materials under cover of FDA Form 2253.
• Maintain stakeholder awareness on planned and approved label updates and how they impact Promotional and Medical materials. Provide key stakeholders with guidance on implementation of ISI, and labels
• Align and maintain effective communication channels with Medical, Marketing, Regulatory, Legal, and corporate counterparts.
• Assist on the development strategies of US labeling to ensure support for anticipated promotional messages and claims.

Qualifications

• Requires a BA/BS degree in a scientific discipline and advanced scientific degree preferred.
• 7+ years of Pharmaceutical/Biotech industry experience in drug advertising and promotion review
• 4+ years' experience as the primary Regulatory representative in the review of prescription drug advertising and promotion for compliance with applicable FDA laws, regulations, and
• Proficiency using promotional review software, such as Veeva Promomats.