Immunology Global Regulatory Director: Strategy & Approvals

Merck; Richmond (VA); Remote; USD 173,000 - 273,000; Full time

Job summary

Merck & Co., Inc. in Rahway, NJ, USA, seeks a Director (Principal Scientist) to lead worldwide regulatory strategies for Immunology projects and serve as the global regulatory lead on cross-functional teams.

You will interact with FDA/EMA and coordinate international submissions, aiming for the fastest time to approval. The role requires senior-level experience in regulatory affairs, immunology exposure, and strong leadership to oversee global programs across indications and external

Qualifications

• Strong strategic thinking, problem-solving, and continuous learning mindset.
• Effective communicator—written and verbal—with the ability to influence, lead, and negotiate across levels and functions.
• Experience leading or supporting direct interactions with major Health Authorities (e.g., FDA, EMA).
• Demonstrated expertise in leading regulatory filings across global regions.
• Therapeutic area expertise in immunology.
• Small and large molecule experience.
• Regulatory affairs experience in major markets (US, EU, Japan, China).

Responsibilities

• Develops worldwide product regulatory strategies to optimize labeling and obtain shortest time to approval.
• Assesses regulatory/competitive landscape to establish global regulatory strategies that facilitate speed-to-market and labeling.
• Provides expert advice as the Global Regulatory Lead to Product Development Teams and regulatory single point-of-contact for products.
• Provides leadership to the Global Regulatory Team which coordinates cross-functional regulatory support for development programs and marketed products.
• Coordinates the preparation, submission and follow-up contact with regulatory agencies and/or subsidiaries for all applications and submissions.
• Reviews and provides final approval of local registration study protocols when needed to obtain marketing authorization in secondary markets.
• Interact independently with regulatory agencies (FDA, EMA), including leading meetings and written communications.
• Coordinate regional regulatory strategy and submissions through collaboration with Regulatory Affairs Europe (RAE) and local affiliate teams.
• Reviews Worldwide Marketing Applications, Clinical Study Reports, protocols, Investigator Brochures.
• Prepares IND/CTAs for global studies related to investigational drugs/biologics.
• Participates in regulatory due diligence activities for licensing candidate reviews

Skills

Drug Development

Global Regulatory

Pharmaceutical Industry

Pharmaceutical Research

Product Registrations

Regulatory Affairs Management

Regulatory Communications

Regulatory Processes

Regulatory Strategies

Regulatory Submissions

Strategic Leadership

Education

B.S./M.S. with 7+ years drug development experience

MD/PhD/PharmD with 5+ years drug development incl regulatory

Job description

Merck & Co., Inc. in Rahway, NJ, USA, seeks a Director (Principal Scientist) to lead worldwide regulatory strategies for Immunology projects and serve as the global regulatory lead on cross-functional teams.

You will interact with FDA/EMA and coordinate international submissions, aiming for the fastest time to approval. The role requires senior-level experience in regulatory affairs, immunology exposure, and strong leadership to oversee global programs across indications and external