Global Regulatory Lead – Immunology (Remote)

Merck; Concord (NH); Remote; USD 173,000 - 273,000; Full time

Job summary

Merck & Co., Inc. invites a seasoned Director (Principal Scientist) to lead worldwide regulatory strategies across immunology programs. The role drives labeling optimization, timelines, and global submissions with a proactive, cross-functional team approach.

You will engage with FDA/EMA and other authorities, guiding lifecycle regulatory activities and program strategy. Strong immunology background preferred.

Qualifications

• B.S./M.S. with a minimum of 7 years in drug development with regulatory focus.
• M.D./PhD/PharmD with a minimum of 5 years relevant drug development experience with three years in regulatory.

Responsibilities

• Develops worldwide regulatory strategies to optimize labeling and obtain shortest time to approval by regulatory agencies.
• Interacts with FDA/EMA and global regulatory agencies as the lead contact for regulatory strategy.
• Provides leadership to cross-functional teams coordinating regulatory support across development programs and marketed products.
• Coordinates preparation, submission and follow-up with regulatory agencies and subsidiaries for all applications and submissions.
• Reviews and approves local registration study protocols for marketing authorization in secondary markets.

Skills

Drug Development

Global Regulatory

Pharmaceutical Industry

Pharmaceutical Research

Product Registrations

Regulatory Affairs

Regulatory Communications

Regulatory Processes

Regulatory Strategies

Regulatory Submissions

Strategic Leadership

Education

B.S. or M.S.

M.D. or PhD/PharmD

Job description

Merck & Co., Inc. invites a seasoned Director (Principal Scientist) to lead worldwide regulatory strategies across immunology programs. The role drives labeling optimization, timelines, and global submissions with a proactive, cross-functional team approach.

You will engage with FDA/EMA and other authorities, guiding lifecycle regulatory activities and program strategy. Strong immunology background preferred.