Senior Regulatory Affairs Lead for FDA Promotions

Merck & Co.; North Wales (Montgomery County); Hybrid; USD 129,000 - 203,000; Full time

Job summary

Merck & Co. in the United States seeks a regulatory affairs professional to serve as liaison with FDA promotional review divisions (OPDP/APLB) and manage complex regulatory inquiries for advisory comment.

You will propose compliant regulatory strategies for promotional concepts, provide regulatory guidance for US marketing programs, and support commercial teams with material reviews to ensure alignment with US regulations and company standards.

Qualifications

• BA/BS in science, healthcare or related fields.
• Preferred MS/PhD/PharmD with emphasis in science/healthcare.

Responsibilities

• Serve as liaison with FDA promotional review divisions and manage complex regulatory questions.
• Propose compliant regulatory strategies that align with business objectives.
• Provide regulatory consultation in US marketing strategy and promos.
• Support commercial teams with regulatory guidance on materials and tactics.
• Participate in labeling and global regulatory meetings to support promotional messages.

Skills

FDA Regulations

Regulatory Submissions

Promotional Review

Cross-Functional Collaboration

Negotiation

Strategic Thinking

Stakeholder Management

US Regulatory Affairs

eCTD

Education

Bachelor's in Science

Master's/PhD/PharmD preferred

Tools

eCTD

Job description

Merck & Co. in the United States seeks a regulatory affairs professional to serve as liaison with FDA promotional review divisions (OPDP/APLB) and manage complex regulatory inquiries for advisory comment.

You will propose compliant regulatory strategies for promotional concepts, provide regulatory guidance for US marketing programs, and support commercial teams with material reviews to ensure alignment with US regulations and company standards.