Global Regulatory Lead – Immunology (Remote)

Merck; Atlanta (GA); Remote; USD 173,000 - 273,000; Full time

Benefits offered by this job

Medical, dental, vision coverage

401(k) retirement benefits

Paid holidays

Vacation

Sick days

Job summary

Merck is seeking a Director (Principal Scientist), Global Regulatory Liaison to develop and implement global regulatory strategies for Immunology programs. You will lead regulatory activities to optimize labeling and shorten time to approval across projects, interacting with regulatory authorities worldwide.

You will independently manage projects as the global single point of contact, coordinating with GRACS and affiliates, and providing leadership to cross-functional teams throughout the drug

Qualifications

• B.S. or M.S with ≥7 years in drug development, primarily regulatory.
• M.D. or Ph.D./PharmD with ≥5 years, incl. ≥3 in regulatory.
• Strong strategic thinking and effective communication across levels.
• Experience leading interactions with major Health Authorities (FDA, EMA).
• Immunology background preferred.

Responsibilities

• Develops worldwide regulatory strategies to optimize labeling and approvals.
• Lead and coordinate cross-functional teams as Global Regulatory Lead.
• Coordinate submissions and regulatory activities with agencies and affiliates.
• Interact with FDA/EMA and other regulatory authorities.
• Provide leadership to the Global Regulatory Team on lifecycle regulatory support.
• Prepare IND/CTAs for global studies.

Skills

Drug Development

Global Regulatory

Regulatory Strategy

Regulatory Submissions

Strategic Leadership

Regulatory Communications

Education

B.S. or M.S.

M.D. or Ph.D./PharmD

Job description

Merck is seeking a Director (Principal Scientist), Global Regulatory Liaison to develop and implement global regulatory strategies for Immunology programs. You will lead regulatory activities to optimize labeling and shorten time to approval across projects, interacting with regulatory authorities worldwide.

You will independently manage projects as the global single point of contact, coordinating with GRACS and affiliates, and providing leadership to cross-functional teams throughout the drug