Global Regulatory Lead — Immunology (Remote)

Merck; Carson City (NV); Remote; USD 191,000 - 300,000; Full time

Job summary

Merck seeks a Senior Director (Sr. Principal Scientist) in Regulatory Affairs Liaison to lead worldwide regulatory strategies for immunology-focused programs.

You will act as the global point of contact, guiding development teams and coordinating with regulatory agencies to optimize labeling and accelerate approvals. Ideal candidates bring 10+ years in regulatory drug development, experience with major health authorities, and proven leadership across global programs.

Qualifications

• Strong regulatory leadership and strategic thinking.
• Experience interacting with major Health Authorities (FDA/EMA).
• Global regulatory affairs experience across major markets (US, EU, Japan, China).

Responsibilities

• Develops worldwide regulatory strategies to optimize labeling and speed approvals.
• Leads regulatory meetings with health authorities and cross-functional teams.
• Manages global regulatory submissions and lifecycle management of programs.

Skills

Global Regulatory

Regulatory Strategy

Drug Development

Regulatory Leadership

Communication

Education

B.S./M.S. in a relevant field

M.D./PhD/PharmD

Job description

Merck seeks a Senior Director (Sr. Principal Scientist) in Regulatory Affairs Liaison to lead worldwide regulatory strategies for immunology-focused programs.

You will act as the global point of contact, guiding development teams and coordinating with regulatory agencies to optimize labeling and accelerate approvals. Ideal candidates bring 10+ years in regulatory drug development, experience with major health authorities, and proven leadership across global programs.