Director of Regulatory Advertising Strategy

Merck; Rahway (NJ); Hybrid; USD 173,000 - 273,000; Full time

Benefits offered by this job

Healthcare benefits

401(k) retirement plan

Paid time off

Job summary

Merck seeks an Individual Contributor Director to lead the review and approval of US promotional materials, acting as the regulatory expert across regulatory, medical, and commercial teams.

The role interfaces with FDA divisions (OPDP/APLB), develops compliant promotional strategies, and ensures alignment with marketing plans, labeling, and study results usage in US promotion. Hybrid work in the USA is supported.

Qualifications

• Minimum 10 years in pharma/biologics with emphasis in regulatory or scientific disciplines.
• Minimum 5 years as primary reviewer of advertising and promotional materials.
• Deep understanding of FDA regulations and company policies related to promotion development and review.

Responsibilities

• Review and approve US promotional materials as a senior regulatory lead.
• Lead liaison with FDA divisions (OPDP/APLB) for advisory comments.
• Develop compliant promotional regulatory strategies aligned with business objectives.
• Partner with review, compliance and commercial teams to ensure cohesive regulatory strategy across development to marketing.
• Lead GTPI-related promotional regulatory strategy and content solutions.
• Identify regulatory solutions in labeling and clinical design related to US promotion.
• Maintain expert understanding of FDA advertising regulations and PhRMA Code, guiding compliant practices.
• Mentor and train team members, and lead strategic regulatory initiatives.

Skills

Advertising Compliance

Cross-Functional Teamwork

FDA Regulations

Pharmaceutical Advertising

Regulatory Affairs

Regulatory Strategies

Strategic Thinking

Team Collaboration

Negotiation

Detail-Oriented

Policy Implementation

Problem Solving

PhRMA Code

Communication

Regulatory Risk

Education

Bachelor's degree in science/healthcare or related fields

Master’s/PhD/PharmD in science/healthcare (preferred)

Job description

Merck seeks an Individual Contributor Director to lead the review and approval of US promotional materials, acting as the regulatory expert across regulatory, medical, and commercial teams.

The role interfaces with FDA divisions (OPDP/APLB), develops compliant promotional strategies, and ensures alignment with marketing plans, labeling, and study results usage in US promotion. Hybrid work in the USA is supported.