Manager, Regulatory Affairs, Advertising & Promotion

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. In this role, you will 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).

This individual will provides regulatory advertising and promotion expertise to relevant stakeholders, typically carrying out the responsibilities with guidance from the Regulatory Affairs, Advertising and Promotion Director. The Manager Regulatory Affairs, Advertising and Promotion will oversee therapeutic area(s) and ensure that messages are translated into advertising and promotion initiatives that meet the commercial team’s objectives, while maintaining the necessary state of 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.

• Work Location:
  
  Sleepy Hollow, NY or Warren, NJ

• 4 days per week on site

• 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

• 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; in partnership with management, provide guidance to stakeholders with respect to impact of enforcement activities on the company policies.

• 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.

• 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…