Manager, Regulatory Affairs - Advertising & Promotion

Role Summary

Manager, Regulatory Affairs - Advertising & Promotion is a role within Regulatory Affairs responsible for applying clinical development knowledge and advertising and promotion regulations to develop key product messages for BLAs and MAAs, providing regulatory advertising and promotion expertise to stakeholders, and ensuring communications meet compliance and corporate integrity across therapeutic areas.

Responsibilities

• Manage US regulatory activities related to advertising and promotion of the company‚Äôs marketed products, with guidance from the Regulatory Affairs, Advertising & Promotion Director.
• Contribute to the development of product messages and materials across multiple functional areas.
• Provide timely regulatory advice to Commercial teams and Medical Affairs regarding conference exhibits, disease awareness, and speaker programs.
• Review US and Global product and disease state materials/communications to support corporate goals and ensure compliance with laws and guidelines.
• Collaborate cross-functionally with Marketing, Medical Affairs, and Legal.
• Establish working relationships and manage communication with regulatory advertising and promotion professionals at co-promote partner companies.
• Lead interactions with the FDA Office of Prescription Drug Promotion (OPDP), maintaining effective communication with FDA reviewers on advertising and promotion matters, including advisory submissions.
• Ensure compliance with promotional material submissions to FDA on Form 2253.
• Monitor external regulatory environment to advise product teams on evolving promotional requirements; provide updates on enforcement activities and guidance on policy impact.
• Identify process improvements for promotional review activities to standardize policies portfolio-wide.
• Cross-train across products/indications to ensure continuous Regulatory A&P support.
• Collaborate with Regulatory Therapeutic Area Leads to review marketing application summaries and study reports.
• Provide input during review cycles to reflect commercialization objectives in submission documents/reports to health authorities.
• Contribute to labeling development and negotiation to reflect commercialization objectives and messages impacting promotion and advertising.

Qualifications

• 2 to 3 years within regulatory affairs, preferably in advertising and promotion, or completion of a Post-Doctoral Fellowship in Regulatory Affairs including Advertising and Promotion, with 1 year of work experience.
• Advanced scientific degree (MS, PharmD, PhD) or Bachelor‚Äôs degree in Life Sciences from an accredited institution.
• Knowledge of regulations and guidelines related to pharmaceutical product development and marketing, with focus on advertising and promotion.
• Experience with pharmaceutical products; biologics experience is a plus.
• Experience working with the FDA, specifically OPDP/APLB, is preferred.
• Ability to review promotional materials and interact with FDA OPDP/APLB; strong written and verbal communication for strategic regulatory advice.
• Ability to support global promotional review and understanding of clinical trial recruitment materials; familiarity with labeling regulations is desirable.
• Ability to influence cross-functional teams and interact with senior management.

Skills

• Regulatory affairs expertise in advertising and promotion
• Cross-functional collaboration
• Regulatory submission and interaction with FDA
• Strategic regulatory guidance for promotion and messaging
• Communication and documentation accuracy

Education

• Degree in Life Sciences (BS) required; advanced degree (MS, PharmD, PhD) preferred.