Remote Global Regulatory Lead, Immunology

Merck; Washington (District of Columbia); Remote; USD 191,000 - 300,000; Full time

Job summary

Merck is seeking a Senior Director (Sr. Principal Scientist) Regulatory Affairs Liaison to lead worldwide regulatory strategies for General Medicine Immunology programs.

You will serve as single global point of contact, shaping labeling and submissions to accelerate approvals with major health authorities. This role requires strategic leadership, independent program management, and experience guiding regulatory discussions with agencies like FDA/EMA, and cross-functional teams across R&D,

Qualifications

• Minimum education: B.S. or M.S with 10+ years in drug development regulatory work; M.D./PhD/PharmD with 7+ years in regulatory
• Strong strategic thinking, problem solving and continuous learning mindset
• Experience leading interactions with major Health Authorities (e.g., FDA, EMA)
• Global regulatory affairs across US, EU, Japan, China

Responsibilities

• Develops worldwide regulatory strategies to optimize labeling and accelerate approvals
• Leads regulatory meetings with agencies and coordinates global submissions
• Provides expert regulatory advice as Global Regulatory Lead to Product Development Teams
• Coordinates cross-functional regulatory support for development programs
• Reviews regulatory documentation and ensures alignment with lifecycle needs
• Manages regulatory due diligence for licensing candidates

Skills

Regulatory Strategy

Global Regulatory

FDA interactions

Leadership

Strategic thinking

Education

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

M.D./PhD/PharmD

Job description

Merck is seeking a Senior Director (Sr. Principal Scientist) Regulatory Affairs Liaison to lead worldwide regulatory strategies for General Medicine Immunology programs.

You will serve as single global point of contact, shaping labeling and submissions to accelerate approvals with major health authorities. This role requires strategic leadership, independent program management, and experience guiding regulatory discussions with agencies like FDA/EMA, and cross-functional teams across R&D,