BioSpace is hiring : Associate Director, Regulatory Advertising & Promotion in Vi

Associate Director, Regulatory Advertising & Promotion

Regeneron is seeking an Associate Director, Regulatory Advertising & Promotion to join the Regulatory Affairs Organization and the Advertising & Promotion team.

Role overview

This position requires applying clinical development knowledge along with a strong understanding of advertising and promotion regulations and guidances to develop key product messages for Biologic License Applications (BLAs) and Marketing Authorization Applications (MAAs). The role provides regulatory advertising and promotion expertise to stakeholders and typically operates with a high degree of independence. The Associate Director will ensure messages are translated into advertising and promotion initiatives that align with commercial objectives while maintaining compliance and corporate integrity.

Key responsibilities

• Manage US and global regulatory activities related to advertising and promotion of marketed products and pipeline products in development.
• Independently manage commercial activities from a regulatory advertising and promotion perspective.
• Advise on the development of product messages and materials across multiple functional areas.
• Provide regulatory guidance to Commercial teams and Medical Affairs for conference exhibit activities, disease awareness, and speaker programs.
• Review US and global product and disease-state materials to support corporate goals while ensuring compliance with laws, regulations, and guidance.
• Collaborate cross-functionally with Marketing, Medical Affairs, Legal, and other stakeholders.
• Establish working relationships with regulatory advertising and promotion professionals at co-promote partner companies.
• Lead interactions with the FDA Office of Prescription Drug Promotion (OPDP); maintain effective communication with FDA reviewers on advertising and promotion matters, including advisory submissions.
• Ensure compliance with promotional material submissions to the FDA on Form 2253.
• Monitor regulatory environment to advise product teams on evolving requirements for product and disease-state communications.
• Provide updates on FDA promotional enforcement activities and advise on impact to company policies.
• Suggest process improvements for promotional review activities and standardize portfolio-wide policies.
• Cross-train across products / indications to ensure continuous Regulatory A&P support for stakeholders.
• Collaborate with Regulatory Therapeutic Area Leads to review marketing application summaries and study reports.
• Provide input during review cycles to align submissions with commercialization objectives and messages.
• Contribute to labeling development and negotiations to reflect commercialization objectives and promotional messages.

Basic qualifications

Additional details

Salary

$173,500.00 - $283,100.00 per year

Job details

Regeneron is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion or belief, sex, nationality, ethnic origin, civil status, age, citizenship status, sexual orientation, disability, genetic information, or any other protected characteristic. Reasonable accommodations are provided as required by law.

For roles in the U.S., salary ranges shown comply with U.S. law and apply to U.S.-based positions. For roles outside the U.S., speak with your recruiter about location-specific salaries and benefits. Background checks may be conducted as part of the recruitment process to verify information such as identity and education.

Note : The content above reflects the responsibilities and qualifications for the Associate Director, Regulatory Advertising & Promotion role as published.

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