Global Regulatory Strategist, Immunology — Remote

Merck; Juneau (AK); Remote; USD 173,000 - 273,000; Full time

Benefits offered by this job

Medical, dental, vision benefits

401(k) retirement plan

Job summary

Merck seeks a Director (Principal Scientist), Global Regulatory Liaison to architect worldwide regulatory strategies across Immunology programs. The role leads global regulatory teams, interfaces with FDA, EMA and other authorities, and coordinates submissions for investigational and marketed products.

The candidate will optimize labeling, ensure compliance across regions, and drive rapid approvals while managing complex programs with internal and external partners.

Qualifications

• B.S. or M.S with a minimum of 7 years of relevant drug development experience with majority in regulatory or
• M.D. or 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 speed to market.
• Coordinates preparation, submission and follow-up with regulatory agencies and subsidiaries.
• Provides leadership to the Global Regulatory Team coordinating cross-functional regulatory support.
• Interacts with regulatory agencies (FDA, EMA) including meetings, teleconferences, and written communications.

Skills

Global Regulatory

Regulatory Strategy

Regulatory Submissions

Regulatory Affairs

Drug Development

Strategic Leadership

Immunology

FDA/EMA interactions

Regulatory Communications

Regulatory Processes

Education

Bachelor/Master in relevant field

MD/PhD/PharmD with regulatory experience

Job description

Merck seeks a Director (Principal Scientist), Global Regulatory Liaison to architect worldwide regulatory strategies across Immunology programs. The role leads global regulatory teams, interfaces with FDA, EMA and other authorities, and coordinates submissions for investigational and marketed products.

The candidate will optimize labeling, ensure compliance across regions, and drive rapid approvals while managing complex programs with internal and external partners.