Manager, Regulatory Affairs, Advertising & Promotion

About the role

Build our future together:
At Regeneron, we use science and innovation to develop life-changing medicines for people with serious diseases. We are seeking a Manager to join our Regulatory Affairs Advertising and Promotion team.

Responsibilities

• Management of US regulatory activities associated with advertising and promotion of the company’s marketed products.
• Manages commercial activities from a regulatory advertising and promotion perspective with guidance from the Regulatory Affairs, Advertising & Promotion Director.
• Creatively contribute to the advise on the development of product messages and materials across multiple functional areas.
• Provide timely regulatory advice and guidance, with guidance from Regulatory Affairs, Advertising & Promotion Director, to Commercial teams and Medical Affairs with respect to conference exhibit activities, disease awareness and speaker programs.
• Provide review of US and Global (if applicable) product and disease state materials/communications, with 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.
• Responsible for establishing working relationship and managing communication with regulatory advertising and promotion professionals at co-promote partner companies.
• 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.
• Responsible for compliance with promotional material submissions to FDA on Form 2253.
• Maintain vigilance with respect to FDA promotional enforcement activities; provide stakeholders with updates on a regular basis; in partnership with management, provide guidance to stakeholders with respect to impact of enforcement activities on the company policies.
• Able to identify process improvement for promotional review activities that would enable the establishment of portfolio wide standardization of policies.
• Able to cross train across products/indications to ensure continuous Regulatory A&P support is provided to stakeholders.
• Collaboration with Regulatory Therapeutic Area Leads to review key marketing application summary documents and study reports.
• With 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 2 total years relevant experience, preferably within Regulatory Advertising and Promotion.
• At minimum, a Bachelor's degree (BS) from an accredited college or university in Life Sciences. An Advanced Scientific degree (i.e., Masters, PharmD, Ph.D) is preferred.
• 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 support launch products/campaigns, while maintaining excellent written/verbal communication skill when giving strategic regulatory advice.
• Ability to support global promotional review, understanding of clinical trial recruitment materials, and familiarity with labeling regulations is desirable.

Qualifications

• Ability to identify process improvement for promotional review activities that would enable the establishment of portfolio wide standardization of policies.
• Ability to cross train across products/indications to ensure continuous Regulatory A&P support is provided to stakeholders.
• Collaboration with Regulatory Therapeutic Area Leads to review key marketing application summary documents and study reports.
• With 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.

Skills

• Strong knowledge of regulations, guidelines, and precedents related to pharmaceutical product development and marketing, with a focus on advertising and promotion.
• Excellent written and verbal communication skills.
• Ability to manage and prioritize multiple tasks and projects simultaneously.
• Experience working with FDA and other regulatory bodies.
• Strong analytical and problem-solving skills.
• Ability to work independently and as part of a team.

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
• Family support benefits

Pay

$128,600.00 - $210,000.00 annually

Schedule

Hybrid: 4 days per week on site