Senior Manager/Associate Director Regulatory Ad Promo & Labeling

Senior Manager/Associate Director, Regulatory Affairs – Advertising & Promotion
About the Opportunity
A growing biopharmaceutical company is seeking an experienced Senior Manager/Associate Director, Regulatory Affairs – Advertising & Promotion to provide strategic regulatory guidance across commercial products and disease areas. This individual will serve as a key partner to Marketing, Medical Affairs, Legal, Commercial Operations, and Regulatory teams to ensure promotional communications comply with applicable regulations while supporting business objectives.

The ideal candidate will bring deep expertise in pharmaceutical advertising and promotion regulations, strong cross-functional leadership skills, and experience interacting with regulatory authorities regarding promotional matters.

Key Responsibilities

Provide strategic regulatory guidance for promotional, educational, and disease awareness materials.

Review and approve promotional communications to ensure consistency with approved labeling and applicable regulatory requirements.

Partner closely with Marketing, Medical Affairs, Commercial Operations, Legal, and Regulatory colleagues to support brand initiatives.

Serve as a key contributor to promotional review committees and cross-functional governance processes.

Advise teams on evolving regulatory requirements, industry trends, and enforcement actions related to pharmaceutical advertising and promotion.

Support interactions with regulatory agencies regarding promotional activities and submissions.

Ensure timely and compliant submission of promotional materials to regulatory authorities.

Develop and deliver training on advertising and promotion regulations and best practices.

Drive continuous improvement of promotional review processes and procedures.

Build strong collaborative relationships across the organization while balancing compliance and business objectives.

Qualifications

Significant experience within Regulatory Affairs, including substantial Advertising & Promotion experience in the pharmaceutical or biotechnology industry.

Strong knowledge of FDA advertising and promotion regulations, guidance, and industry standards.

Experience supporting promotional review committees, copy review processes, and commercial product launches.

Familiarity with promotional submissions and regulatory agency interactions related to advertising and promotion.

Strong understanding of clinical data and ability to evaluate promotional claims and scientific communications.

Excellent communication, influencing, and stakeholder management skills.

Proven ability to work effectively within cross-functional teams and navigate complex business environments.

Why Consider This Opportunity?

High-visibility role partnering closely with commercial leadership.

Opportunity to influence promotional strategy across multiple brands and therapeutic areas.

Significant cross-functional exposure across Regulatory, Medical Affairs, Marketing, and Legal.

Dynamic environment with meaningful impact on commercial success and compliance.

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