Promotional Regulatory Strategy Lead

Merck; Rahway (NJ); Hybrid; USD 129,000 - 203,000; Full time

Job summary

Merck in the United States seeks an Associate Director to oversee the review and approval of all US promotional materials, acting as the regulatory expert alongside legal, medical, and commercial teams to ensure compliance with FDA guidelines and company policies.

The role requires collaboration with FDA divisions (OPDP/APLB), development of compliant strategies, and guidance on marketing tactics. Hybrid work arrangement with onsite days in Rahway, NJ or Upper Gwynedd, PA will be needed.

Qualifications

• Bachelor's degree with emphasis in science, health care or related fields.
• Master’s, PhD or PharmD degree with emphasis in science, health care or related fields.
• Minimum of five years of pharmaceutical/biologics industry experience with emphasis in regulatory or scientific disciplines.
• Minimum of two years as primary regulatory reviewer of advertising and promotional materials.
• Demonstrated knowledge of FDA regulations relating to advertising and promotion for prescription products.

Responsibilities

• Review and approve US promotional materials in line with regulatory guidelines and company policies.
• Liaise with FDA's OPDP/APLB and manage complex regulatory questions and submissions.
• Propose compliant regulatory strategies to meet business objectives and minimize risk.
• Provide regulatory consultation in marketing strategy and promotional programs.
• Support US commercial teams with regulatory guidance on marketing tactics and material reviews.
• Participate in labeling and global regulatory meetings to align messages with study results and labeling.
• Maintain awareness of FDA correspondence, evolving regulations, and enforcement letters.
• Provide regulatory training and coaching to team members and contribute to strategic initiatives.

Skills

Clinical Trials

Cross-Functional Teamwork

Data Analysis

Detail-Oriented

eCTD

FDA Regulations

Negotiation

Pharmaceutical Industry

Promotional Review

Regulatory Compliance

Regulatory Strategies

Regulatory Submissions

Stakeholder Management

Strategic Thinking

US Regulatory Affairs

Education

Bachelor's degree

Master’s/PhD/PharmD preferred

Job description

Merck in the United States seeks an Associate Director to oversee the review and approval of all US promotional materials, acting as the regulatory expert alongside legal, medical, and commercial teams to ensure compliance with FDA guidelines and company policies.

The role requires collaboration with FDA divisions (OPDP/APLB), development of compliant strategies, and guidance on marketing tactics. Hybrid work arrangement with onsite days in Rahway, NJ or Upper Gwynedd, PA will be needed.