Remote Regulatory Affairs: Advertising & Promotion Manager

Regeneron Pharmaceuticals; United States; Hybrid; USD 129,000 - 210,000; Full time

Job summary

Regeneron Pharmaceuticals is seeking a Manager to join the Regulatory Affairs Advertising and Promotion team. This role applies clinical development knowledge and regulatory guidance to craft product messages for BLAs and MAAs, ensuring compliant advertising and promotional materials across functions.

The ideal candidate will lead US regulatory activities for advertising and promotion, advise on messaging, and collaborate with Marketing, Medical Affairs, and Legal to support launches while

Qualifications

• Knowledge of regulations, guidelines and precedents related to pharmaceutical product development and marketing, especially advertising and promotion.
• Experience with pharmaceutical products; biologics experience is a plus.
• Experience with FDA OPDP/APLB interactions and promotional review processes.

Responsibilities

• Manage US regulatory activities related to advertising and promotion of marketed products under guidance from the Director.
• Advise on development of product messages and materials across functional areas.
• Provide regulatory guidance to Commercial teams and Medical Affairs for conferences, disease awareness, and speaker programs.
• Review US and Global product and disease state materials to align with laws and guidance.
• Collaborate with Marketing, Medical Affairs and Legal across functions.
• Establish relationships with regulatory advertising and promotion professionals at co-promote partners.
• Lead interactions with FDA Office of Prescription Drug Promotion (OPDP) for assigned products and maintain communications with FDA reviewers.
• Ensure compliance with promotional material submissions to FDA on Form 2253.
• Monitor regulatory environment and update product teams on requirements and enforcement activities.
• Identify process improvements for promotional review and standardization of policies.
• Cross-train across products to ensure continuous Regulatory A&P support.
• Review marketing application summary documents and study reports with Therapeutic Area Leads.
• Provide input during labeling development and submission cycles to reflect commercialization objectives.

Skills

Regulatory Advertising & Promotion

Cross-functional collaboration

Regulatory submissions/approvals

Strategic regulatory guidance

Education

Bachelor’s degree in Life Sciences

Advanced scientific degree (preferred)

Job description

Regeneron Pharmaceuticals is seeking a Manager to join the Regulatory Affairs Advertising and Promotion team. This role applies clinical development knowledge and regulatory guidance to craft product messages for BLAs and MAAs, ensuring compliant advertising and promotional materials across functions.

The ideal candidate will lead US regulatory activities for advertising and promotion, advise on messaging, and collaborate with Marketing, Medical Affairs, and Legal to support launches while