Global Regulatory Lead, Immunology & Strategy

Merck; Richmond (VA); On-site; USD 191,000 - 300,000; Full time

Job summary

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

You will act as global point of contact, guiding development programs and liaising with agencies to optimize labeling and approvals. This role requires strategic leadership, proactive management of complex programs, and experience with major regulatory authorities.

Qualifications

• Bachelor-level or higher degree in a life sciences field with extensive regulatory experience.
• Experience leading regulatory strategies across global regions including major markets (U.S., EU, Japan, China).
• Strong strategic thinking, problem-solving and leadership capabilities.

Responsibilities

• Develops worldwide regulatory strategies to optimize labeling and shorten time to approval by agencies.
• Leads global regulatory teams and serves as single-point contact for development programs and marketed products.
• Interacts with major Health Authorities (FDA, EMA) and leads regulatory meetings and submissions.

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 minimum 10 years relevant drug development experience

M.D. or PhD/PharmD with minimum 7 years relevant drug development experience with five years in regulatory

Job description

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

You will act as global point of contact, guiding development programs and liaising with agencies to optimize labeling and approvals. This role requires strategic leadership, proactive management of complex programs, and experience with major regulatory authorities.