Manager/Senior Manager Regulatory Affairs Ad/Promo & Labeling

About the Company: A growing biopharmaceutical portfolio focused on innovative therapies.

About the Role: The Manager/Senior Manager, Regulatory Affairs — Advertising, Promotion & Labeling is responsible for supporting U.S. promotional regulatory strategy and related global initiatives.

Responsibilities:

• Serve as the Regulatory Affairs representative for review and approval of promotional, medical, scientific exchange, disease awareness, patient, and healthcare professional materials.
• Provide strategic regulatory guidance on advertising and promotional initiatives to ensure compliance with FDA regulations, industry standards, and internal policies.
• Review materials for accuracy, fair balance, appropriate risk communication, and consistency with approved labeling and supporting scientific evidence.
• Support management and maintenance of core labeling documents, including updates, reviews, approvals, and related regulatory activities.
• Prepare and support submission of regulatory filings associated with promotional materials, including FDA Form 2253 documentation where applicable.
• Partner cross-functionally with Commercial, Medical Affairs, Legal, Clinical, and Regulatory Operations teams on promotional strategy and claims development.
• Monitor evolving regulatory guidance, enforcement trends, and industry best practices related to advertising, promotion, and digital communications.
• Contribute to SOP development, training initiatives, governance processes, and inspection readiness activities.
• Review digital and social media content to ensure compliance with applicable promotional regulations and platform-specific considerations.

Qualifications:

• Bachelor’s degree in a scientific, healthcare, or related discipline required; advanced degree preferred.
• Approximately 4+ years (Manager) or 6+ years (Senior Manager) of Regulatory Advertising & Promotion experience within the pharmaceutical, biotechnology, or life sciences industry.
• Strong understanding of FDA promotional regulations and industry standards related to advertising, labeling, and promotional review.
• Experience participating in Promotional Review Committee (PRC/MLR) processes and supporting promotional submissions.
• Excellent communication, collaboration, and strategic problem-solving skills.
• Ability to work effectively in a fast-paced, cross-functional environment supporting innovative therapies and commercial programs.

Required Skills: Strong understanding of FDA promotional regulations and industry standards related to advertising, labeling, and promotional review.

Preferred Skills: Experience participating in Promotional Review Committee (PRC/MLR) processes and supporting promotional submissions.