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.