Manager, Regulatory Affairs - Advertising & Promotion

Role Summary

Manager, Regulatory Affairs - Advertising & Promotion role within Regulatory Affairs to provide regulatory advertising and promotion expertise for product messages in BLAs/MAAs, overseeing therapeutic areas and ensuring compliant advertising and promotion initiatives.

Responsibilities

• Manage US regulatory activities related to advertising and promotion of the company’s marketed products, with guidance from the Regulatory Affairs, Advertising & Promotion Director.
• Contribute to 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 to support corporate goals and comply with laws, regulations, and guidance.
• 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 and assist interactions with the FDA Office of Prescription Drug Promotion (OPDP), maintaining relationships with FDA OPDP reviewers regarding advertising and promotion matters.
• Ensure compliance with promotional material submissions to FDA on Form 2253.
• Monitor external environment to advise product teams on evolving regulatory requirements for product and disease state communications.
• Maintain vigilance regarding FDA promotional enforcement activities and provide updates; guide stakeholders on impact to company policies.
• 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 key marketing application summary documents and study reports.
• Provide input during review cycles to reflect commercialization objectives in submission documents/reports to health authorities.
• Provide input during labeling development and negotiation to reflect commercialization objectives and messages for promotion and advertising.

Qualifications

• Minimum 2 to 3 years in regulatory affairs, preferably in advertising and promotion, or completion of a Post-Doctoral Fellowship focused on Regulatory Affairs including Advertising and Promotion with 1-year work experience.
• Advanced scientific degree (Masters, PharmD, Ph.D) or Bachelor's degree in Life Sciences.
• 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 while providing strategic regulatory advice.
• Ability to support global promotional review, understanding of clinical trial recruitment materials, and familiarity with labeling regulations is desirable.
• Strong cross-functional collaboration and ability to interact with senior management.

Skills

• Regulatory affairs expertise in advertising and promotion
• Regulatory strategy and advice for commercial activities
• Communication and relationship management with FDA and cross-functional teams
• Materials review for promotional and disease state communications
• Global promotional review and labeling knowledge

Education

• Master’s/PharmD/Ph.D. or Bachelor’s degree in Life Sciences

Additional Requirements

• None specified beyond the above qualifications.