Global Regulatory Lead, Immunology — Remote

Merck; Olympia (WA); Remote; USD 191,000 - 300,000; Full time

Job summary

Merck seeks a Senior Director (Sr. Principal Scientist), Regulatory Affairs Liaison to lead worldwide regulatory strategies for General Medicine developments, with focus on Immunology.

You will be a global single point of contact, coordinating with regulatory authorities and teams to optimize labeling and speed approvals. Ideal candidates bring strategic thinking, strong communication, and a proven record in global regulatory affairs across major markets, including US, EU, Japan, and China.

Qualifications

• BS or MS with 10+ years in drug development regulatory experience
• MD/PhD/PharmD with 7+ years in drug development with five years in regulatory

Responsibilities

• Develops worldwide regulatory strategies to optimize labeling and shorten time to approval.
• Provides expert regulatory advice as Global Regulatory Lead to Product Development Teams.
• Leads cross-functional regulatory support for development programs and marketed products.
• Coordinates submissions with regulatory agencies and manages global registrations.
• Interacts with major Health Authorities (FDA, EMA) and leads regulatory meetings.
• Prepares IND/CTAs for global studies and participates in regulatory due diligence.

Skills

Drug Development

Global Regulatory

Pharmaceutical Industry

Pharmaceutical Research

Product Registrations

Regulatory Affairs Management

Regulatory Communications

Regulatory Documents

Regulatory Processes

Regulatory Strategies

Regulatory Strategy Development

Regulatory Submissions

Strategic Leadership

Education

B.S. or M.S with 10+ years of drug development regulatory experience

M.D. or Ph.D./PharmD with 7+ years in drug development and regulatory

Job description

Merck seeks a Senior Director (Sr. Principal Scientist), Regulatory Affairs Liaison to lead worldwide regulatory strategies for General Medicine developments, with focus on Immunology.

You will be a global single point of contact, coordinating with regulatory authorities and teams to optimize labeling and speed approvals. Ideal candidates bring strategic thinking, strong communication, and a proven record in global regulatory affairs across major markets, including US, EU, Japan, and China.