Director de Asuntos Regulatorios: Promoción y Revisión

Merck; North Wales (Montgomery County); Hybrid; USD 173.000 - 273.000; Vollzeit

Zusammenfassung

Merck in North Wales, PA seeks an Individual Contributor Director to lead the review and approval of U.S. promotional materials, ensuring compliance with FDA regulations and company policies.

You will collaborate with legal, medical, and commercial teams to align messaging with regulatory requirements and business goals. You will serve as the regulatory expert for promotions, manage FDA interactions, and mentor staff while shaping global and local strategies from development through launch.

Qualifikationen

• Minimum of ten years in pharma/biologics with regulatory focus.
• At least five years as primary reviewer of advertising materials.
• Deep understanding of FDA regulations and company policies.

Aufgaben

• Lead the review and approval of US promotional materials with regulatory oversight.
• Liaise with FDA divisions and manage submissions for advisory comment.
• Develop regulatory strategies to meet business objectives while minimizing risk.
• Lead regulatory training and mentor team members.

Kenntnisse

Regulatory experience

FDA regulations

Strategic thinking

Negotiation

Cross-functional collaboration

Pharmaceutical advertising

PhRMA Code

Policy implementation

Problem solving

Regulatory affairs

Team collaboration

Advertising compliance

Ausbildung

Bachelor's degree in science/health care or related fields

Master’s/PhD/PharmD preferred

Jobbeschreibung

Merck in North Wales, PA seeks an Individual Contributor Director to lead the review and approval of U.S. promotional materials, ensuring compliance with FDA regulations and company policies.

You will collaborate with legal, medical, and commercial teams to align messaging with regulatory requirements and business goals. You will serve as the regulatory expert for promotions, manage FDA interactions, and mentor staff while shaping global and local strategies from development through launch.