Hybrid Regulatory Affairs Lead - Promotional Materials

MSD; North Wales (Montgomery County); Hybrid; USD 180.000 - 240.000; Vollzeit

Zusammenfassung

Merck & Co., Inc. in Rahway, NJ is seeking an Associate Director of US Promotional Regulatory Affairs to review and approve all US promotional materials and provide regulatory expertise to commercial teams.

The role requires collaboration with FDA divisions (OPDP/APLB), cross-functional partners, and leadership in strategic regulatory planning. This hybrid position requires onsite work three days per week in Upper Gwynedd, PA or Rahway, NJ.

Qualifikationen

• BA/BS with emphasis in science, health care or related fields.
• Master’s/PhD/PharmD preferred with emphasis in science/health care.
• Minimum five years in pharma/biologics with regulatory focus.
• At least two years as primary regulatory reviewer of ads/promotional materials.
• Proven knowledge of FDA advertising and promotion regs for prescription products.

Aufgaben

• Review and approve US promotional materials for regulatory compliance.
• Serve as regulatory expert with legal, medical, and commercial teams.
• Collaborate with FDA divisions OPDP/APLB on complex questions/submissions.
• Develop regulatory strategies and solutions aligned with business goals.
• Provide regulatory guidance in US marketing strategy and programs.
• Train and coach team members on promotional regulatory topics.

Kenntnisse

FDA Regulations

Promotional Review

Regulatory Compliance

Cross-Functional Teamwork

Strategic Thinking

Negotiation

Stakeholder Management

US Regulatory Affairs

Data Analysis

Ausbildung

Bachelor's in Science

Master's/PhD/PharmD

Tools

eCTD

Jobbeschreibung

Merck & Co., Inc. in Rahway, NJ is seeking an Associate Director of US Promotional Regulatory Affairs to review and approve all US promotional materials and provide regulatory expertise to commercial teams.

The role requires collaboration with FDA divisions (OPDP/APLB), cross-functional partners, and leadership in strategic regulatory planning. This hybrid position requires onsite work three days per week in Upper Gwynedd, PA or Rahway, NJ.