Senior Regulatory Strategy Director (Hybrid)

MSD Malaysia; Northern (KY); On-site; USD 173,000 - 273,000; Full time

Benefits offered by this job

Hybrid work model

Annual bonus

Job summary

Merck & Co., Inc. seeks a Senior Director of Regulatory Affairs to lead a team of promotional regulatory reviewers in the U.S. for advertising and promotion, ensuring compliance with FDA regulations and company policies.

The role drives regulatory strategy across multiple franchises, balancing risk and business goals at the highest level. The position requires strong leadership, strategic thinking, and a track record of cross-functional collaboration with commercial, legal, and medical teams.

Qualifications

• 12+ years in pharmaceutical/biologics regulatory, clinical, medical, legal, or marketing disciplines with advertising/promotional review
• 6+ years reviewing advertising and promotion materials for regulatory compliance
• Expert understanding of FDA regulations and company policies for promotion development and review
• Experience leading cross-functional teams and driving regulatory strategy across multiple franchises

Responsibilities

• Lead a team of promotional regulatory reviewers to provide regulatory strategy across therapeutic franchises
• Partner with commercial and stakeholders to align regulatory strategy with business goals
• Oversee product labeling, regulatory submissions, and promotional messaging to ensure compliance
• Guide senior leadership on regulatory risk assessments and policy changes
• Represent the company in external regulatory meetings and industry forums

Skills

Regulatory leadership

Cross-functional collaboration

FDA regulations

Strategic planning

Negotiation

Communication

Team leadership

Regulatory strategy

Education

Bachelor’s degree in science

Advanced degree preferred

Science-related background

Job description

Merck & Co., Inc. seeks a Senior Director of Regulatory Affairs to lead a team of promotional regulatory reviewers in the U.S. for advertising and promotion, ensuring compliance with FDA regulations and company policies.

The role drives regulatory strategy across multiple franchises, balancing risk and business goals at the highest level. The position requires strong leadership, strategic thinking, and a track record of cross-functional collaboration with commercial, legal, and medical teams.