Senior Manager, Regulatory Affairs, Advertising & Promotion

About the role

This position requires the ability to apply clinical development knowledge in concert with experienced understanding of advertising and promotion regulations/guidance to the development of key product messages presented in Biologic License Applications (BLAs) and Marketing Authorization Applications (MAAs). They will provide regulatory advertising and promotion expertise to relevant stakeholders, typically carrying out the responsibilities with minimal guidance from the Regulatory Affairs, Advertising and Promotion Director.

Responsibilities

• Manage US and Global (if applicable) regulatory activities associated with advertising and promotion of the company’s marketed products, as well as commercial development of pipeline products.
• Manage commercial activities from a regulatory advertising and promotion perspective with minimal guidance from the Regulatory Affairs, Advertising & Promotion Director.
• Creatively advise on the development of product messages and materials across multiple functional areas.
• Provide timely regulatory advice and guidance, with minimal guidance from Regulatory Affairs, Advertising & Promotion Director, to Commercial teams and Medical Affairs with respect to conference exhibit activities, disease awareness and speaker programs.
• Review US and Global (if applicable) product and disease state materials/communications, with minimal guidance from Regulatory Affairs, Advertising & Promotion Director, to support corporate goals and comply with applicable laws, regulations, and guidance.
• Collaborate cross-functionally with key stakeholders in areas such as Marketing, Medical Affairs, and Legal.
• Help lead and assist in all interactions with the FDA Office of Prescription Drug Promotion (OPDP) for assigned company products, responsible for helping to maintain working relationship and effective communication with FDA OPDP reviewers with respect to advertising and promotion matters, including request for advisory submissions.
• Monitor the external environment to advise product teams on evolving regulatory requirements related to product and disease state communications.
• Maintain vigilance with respect to FDA promotional enforcement activities; provide stakeholders with updates on a regular basis; provide guidance to stakeholders with respect to impact of enforcement activities on the company policies.
• Provide input to direct management with respect to process improvement for promotional review activities and establishment of portfolio wide standardization of policies.
• Collaborate with Regulatory Therapeutic Area Leads to review key marketing application summary documents and study reports.
• With minimal guidance from management, help provide input during review cycles to reflect commercialization objectives and messages in the submission documents/reports that are submitted to health authorities.
• Provide input to management during labeling development and negotiation to reflect commercialization objectives and messages that impact promotion and advertising.

Requirements

• A minimum of 3 to 4 years within regulatory affairs, preferably within advertising and promotion.
• A minimum of a Bachelor’s degree (BS) from an accredited College or University in Life Sciences. An advanced degree (Masters, Pharm D, Ph.D., MD or DO) is preferred in the field of medicine or science.
• Advance knowledge of regulations, guidelines and precedents related to pharmaceutical product development and marketing, with focus in the area of advertising and promotion.
• Experience with pharmaceutical products required, biologics experience is a plus.
• Experience working directly/indirectly with the FDA, specifically OPDP/APLB is preferred.
• Ability to review promotional materials and interact with FDA OPDP/APLB and managing launch products/campaigns, while maintaining excellent written/verbal communication skill when giving strategic regulatory advice.
• Experience supporting global promotional review, understanding of clinical trial recruitment materials, and familiarity with labeling regulations is desirable.

Qualifications

• Ability to cross train across products/indications to ensure continuous Regulatory A&P support is provided to stakeholders.

Skills

• Strong knowledge of advertising and promotion regulations/guidance.
• Excellent written and verbal communication skills.
• Ability to influence cross-functional teams and interact with senior management.

Benefits

Regeneron offers a competitive and comprehensive total rewards package which may include, depending on country and role: annual bonuses or other incentive plans, equity awards, pension or retirement benefits, 401(k) company match, health and wellness programs, fitness centers, insurance benefits (e.g. medical, dental, vision, life and disability), paid time off, and family support benefits. For additional information about Regeneron benefits in the U.S., please visit here.

Pay

$150,500.00 - $245,500.00 annually

Schedule

Hybrid: 4 days per week on site