[Hiring] Associate Manager, Regulatory Advertising & Promotion @Regeneron Pharmaceuticals

Role Description

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

The Associate Manager position within the Regulatory Affairs department requires the ability to apply clinical development knowledge in concert with experienced understanding of advertising and promotion regulations/guidances to the development of key product messages presented in Biologic License Applications (BLAs) and Marketing Authorization Applications (MAAs).

• Provides regulatory advertising and promotion expertise to relevant stakeholders, typically carrying out the responsibilities with guidance from the Regulatory Affairs, Advertising and Promotion Director.
• Oversees therapeutic area(s) and ensures that messages are translated into advertising and promotion initiatives that meet the commercial team’s objectives, while maintaining compliance and corporate integrity.

This position offers the opportunity to contribute to a fast-growing, science-driven organization making a meaningful difference to patients worldwide.

Qualifications

• A minimum of 1 to 2 years within regulatory affairs, preferably within advertising and promotion or completion of a Post-Doctoral Fellowship Program with related experience focused on Regulatory Affairs, including Advertising and Promotion.
• Advanced scientific degree (i.e., Masters, PharmD, Ph.D) strongly preferred. Minimum requirement is a Bachelor's degree (BS) from an accredited college or university in Life Sciences.
• Fundamental understanding 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 is highly preferred, biologics experience is a plus.
• Experience working directly/indirectly with the FDA, specifically OPDP/APLB is desirable.
• Ability to review promotional materials and interact with FDA OPDP/APLB and help support launch products/campaigns, while maintaining excellent written/verbal communication skills.
• Familiarity with global promotional review, clinical trial recruitment materials, and labeling regulations is desirable.
• Ability to influence and guide cross-functional teams.
• Ability to interact effectively with senior management and colleagues at all levels.

Requirements

• Contribute to the management of US regulatory activities associated with advertising and promotion of the company’s marketed products.
• Manage commercial activities from a regulatory advertising and promotion perspective with guidance from the Regulatory Affairs, Advertising & Promotion Director.
• Advise on the development of product messages and materials across multiple functional areas.
• Provide timely regulatory advice and guidance to Commercial teams and Medical Affairs regarding conference exhibit activities, disease awareness, and speaker programs.
• Review US and Global product and disease state materials/communications 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.
• Contribute to the working relationship and communication with regulatory advertising and promotion professionals at co-promote partner companies.
• Assist with interactions with the FDA Office of Prescription drug Promotion (OPDP) for assigned company products.
• Maintain compliance with promotional material submissions to FDA on Form 2253.
• 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.
• Assess the potential impact of enforcement activities on company policies.
• Knowledge of process improvement for promotional review activities to establish portfolio-wide standardization of policies.
• Knowledge of products/indications to provide continuous Regulatory A&P support to stakeholders.
• Collaborate with Regulatory Therapeutic Area Leads to review key marketing application summary documents and study reports.
• Understand and work with management during labeling development and negotiation to reflect commercialization objectives and messages that impact promotion and advertising.

Benefits

• 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.

Company Description

Regeneron is committed to building a workplace with an inclusive culture. We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, sexual orientation, gender identity or expression, gender reassignment, marital or civil partnership status, civil status, pregnancy or parental status, age, disability, nationality, citizenship status, ethnic or national origin, membership of the Traveler community, familial status, genetic information, military or veteran status, or any other characteristic protected under applicable law.