Associate Manager, Regulatory Advertising & Promotion (Remote)

Regeneron Pharmaceuticals, Inc.; United States; Remote; USD 110,000 - 140,000; Full time

Job summary

Regeneron Pharmaceuticals, Inc. is seeking an Associate Manager to join the Regulatory Affairs Advertising and Promotion team.

You will apply clinical development knowledge with promotion regulations to craft compliant product messages for BLAs/MAAs, guiding stakeholders and coordinating with Regulatory Affairs leadership. The role emphasizes collaboration across Marketing, Medical Affairs, and Legal, with FDA interactions and promotional material reviews to support corporate goals while

Qualifications

• Bachelor's degree in Life Sciences required; advanced degree preferred.
• 1–2 years in regulatory affairs, advertising and promotion preferred.
• Strong understanding of FDA advertising and promotion regulations and precedents.

Responsibilities

• Contribute to US regulatory activities for advertising and promotion of marketed products.
• Advise on development of product messages across functional areas.
• Provide regulatory guidance to Commercial and Medical Affairs on conferences and speaker programs.
• Review US and Global product materials to ensure compliance.
• Collaborate cross-functionally with Marketing, Medical Affairs and Legal.
• Support communications with co-promote partner companies' regulatory teams.
• Interface with FDA OPDP for assigned products and advisory submissions.
• Ensure compliance with FDA Form 2253 submissions.
• Monitor external environment for evolving regulatory requirements.
• Track FDA enforcement trends and advise impact on policies.
• Identify process improvements for promotional review standardization.
• Support regulatory A&P needs for new products/indications.
• Work with Regulatory Therapeutic Area Leads on key marketing docs.
• Ensure review inputs reflect commercialization objectives in submissions.
• Assist labeling development and negotiation to align messaging.

Skills

Regulatory affairs knowledge

Advertising & Promotion

FDA interactions

Cross-functional collaboration

Communications

Education

Bachelor's degree in Life Sciences

Advanced scientific degree (Masters/PharmD/Ph.D.)

Job description

Build our future together:

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. The Associate 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 needed 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.

When & where:

Work Location: Remote - United States

Remote - 5 days a week

Discover your role:

• Contribute to the 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.
• Contribute to the advisement on the development of product messages and materials across multiple functional areas.
• Assist with providing 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
• Assist with providing 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.
• Ability to collaborate cross functionally with key stakeholders in areas such as Marketing, Medical Affairs, and Legal.
• Contributes to the working relationship and handling of 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, assist with 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; help assess the potential impact of enforcement activities on the company policies.
• Knowledge of process improvement for promotional review activities that would enable the establishment of portfolio wide standardization of policies
• Knowledge of products/indications to help provide 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
• Knowledge of the input provided during review cycles to reflect commercialization objectives and messages in the submission documents/reports that are submitted to health authorities
• Ability to understand and work with management during labeling development and negotiation to reflect commercialization objectives and messages that impact promotion and advertising.

This role requires:

• A minimum of 1 to 2 years within regulatory affairs, preferable 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 lau