Manager Regulatory Affairs, Advertising & Promotion (Remote)

Regeneron Pharmaceuticals

4d • $128,600 - $210,000 • Remote

About The Position

Regeneron is seeking a Manager to join its Regulatory Affairs Advertising and Promotion team. The role applies clinical development knowledge and expertise in advertising and promotion regulations and guidance to the development of key product messages used in Biologic License Applications (BLAs) and Marketing Authorization Applications (MAAs). The Manager provides regulatory advertising and promotion expertise to stakeholders, generally with guidance from the Regulatory Affairs, Advertising and Promotion Director, and oversees therapeutic areas to ensure product messages are translated into compliant advertising and promotion initiatives that support commercial objectives.

The position manages U.S. regulatory activities related to advertising and promotion for marketed products and provides advice to Commercial teams and Medical Affairs. It includes review of U.S. and, where applicable, global product and disease-state materials; collaboration with Marketing, Medical Affairs, Legal, and co-promotion partners; and support for interactions with the FDA Office of Prescription Drug Promotion. The Manager also contributes to marketing application and study-report reviews, labeling development and negotiation, promotional compliance, and process improvements across the portfolio.

The position is remote in the United States. The posting describes the work location as remote and also states “Remote: 5 days per week on site.”

Requirements

• At least 2 years of relevant experience.
• Bachelor’s degree or higher from an accredited college or university in Life Sciences.
• Knowledge of regulations, guidelines, and precedents related to pharmaceutical product development and marketing, particularly advertising and promotion.
• Experience with pharmaceutical products.
• Ability to review promotional materials and support product launches and campaigns.
• Excellent written and verbal communication skills for providing strategic regulatory advice.
• Ability to influence cross-functional teams and collaborate with colleagues at all levels.
• Ability to interact with senior management when needed.

Nice To Haves

• Relevant experience preferably in Regulatory Advertising and Promotion.
• An advanced scientific degree.
• Experience with biologics.
• Experience working directly or indirectly with the FDA, particularly OPDP/APLB.
• Ability to support global promotional review.
• Understanding of clinical trial recruitment materials.
• Familiarity with labeling regulations.

Responsibilities

• Manage U.S. regulatory activities associated with advertising and promotion of the company’s marketed products, with guidance from the Regulatory Affairs, Advertising & Promotion Director.
• Contribute to and advise on the development of product messages and materials across multiple functional areas.
• Provide regulatory advice and guidance to Commercial teams and Medical Affairs regarding conference exhibits, disease-awareness activities, and speaker programs.
• Review U.S. and, where applicable, global product and disease-state materials and communications for alignment with company goals and applicable laws, regulations, and guidance.
• Collaborate with stakeholders in Marketing, Medical Affairs, Legal, and other functions.
• Establish working relationships and manage communications with regulatory advertising and promotion professionals at co-promotion partner companies.
• Help lead interactions with the FDA Office of Prescription Drug Promotion (OPDP) for assigned products, including maintaining effective communication with FDA reviewers on advertising and promotion matters and advisory-submission requests.
• Ensure compliance with promotional material submissions to the FDA on Form 2253.
• Monitor changes in the external regulatory environment and advise product teams about evolving requirements for product and disease-state communications.
• Monitor FDA promotional enforcement activities, regularly update stakeholders, and work with management to advise on their implications for company policies.
• Identify process improvements that can support portfolio-wide standardization of promotional review policies.
• Cross-train across products and indications to help ensure continuous Regulatory Advertising and Promotion support.
• Collaborate with Regulatory Therapeutic Area Leads to review key marketing application summary documents and study reports.
• With management guidance, provide input during review cycles to reflect commercialization objectives and messages in documents and reports submitted to health authorities.
• Provide input to management during labeling development and negotiation on commercialization objectives and messages that affect promotion and advertising.

Benefits

• Annual bonuses or other incentive plans, depending on country and role.
• Equity awards, depending on country and role.
• Pension or retirement benefits, depending on country and role.
• 401(k) company match.
• Health and wellness programs.
• Fitness centers.
• Insurance benefits, including medical, dental, vision, life, and disability coverage.
• Paid time off.
• Family support benefits.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level