Director Regulatorio de Publicidad y Promoción

MSD; Pennsylvania; Hybride; USD 173 000 - 273 000; Plein temps

Avantages offerts par ce poste

Annual bonus

Long-term incentive

Comprehensive benefits package

Résumé du poste

Merck & Co., Inc. in North Wales, PA, is seeking a Director of Regulatory Affairs for Promotion and Advertising Review to lead the US promotional review process and ensure compliance with FDA guidelines and company policy.

You will collaborate with legal, medical, and commercial colleagues to align regulatory strategies with business objectives. The role involves serving as a regulatory expert, managing FDA inquiries (OPDP/APLB), and mentoring a team while driving cross-functional strategies

Qualifications

• Minimum of ten years in pharma/biologics with regulatory focus.
• Five+ years reviewing advertising/promotional materials.
• Deep knowledge of FDA rules and PhRMA Code.

Responsabilités

• Lead development of promotional regulatory strategy for products.
• Review and approve US promotional materials to ensure compliance.
• Act as liaison with FDA promotional divisions OPDP/APLB.
• Mentor and coach team members; drive cross-functional collaboration.

Connaissances

Advertising Compliance

Communication

Cross-Functional Teamwork

Detail-Oriented

FDA Regulations

Negotiation

Pharmaceutical Advertising

PhRMA Code

Policy Implementation

Problem Solving

Regulatory Affairs

Regulatory Risk

Regulatory Strategies

Strategic Thinking

Team Collaboration

Formation

Bachelor's degree in science/healthcare

Master’s/PhD/PharmD in science/healthcare

Outils

FDA regulatory processes

GTPI knowledge

Description du poste

Merck & Co., Inc. in North Wales, PA, is seeking a Director of Regulatory Affairs for Promotion and Advertising Review to lead the US promotional review process and ensure compliance with FDA guidelines and company policy.

You will collaborate with legal, medical, and commercial colleagues to align regulatory strategies with business objectives. The role involves serving as a regulatory expert, managing FDA inquiries (OPDP/APLB), and mentoring a team while driving cross-functional strategies