Remote Global Regulatory Lead, Immunology

Merck; Sacramento (CA); 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, focused on Immunology.

This role serves as the global regulatory lead on complex programs, guiding labeling, submissions, and agency interactions across multiple markets. The ideal candidate brings senior-level regulatory expertise, strategic leadership, and experience with major health authorities (FDA/EMA), and a track record of speeding time to

Qualifications

• B.S. or M.S with a minimum of 10 years of relevant drug development experience with majority in regulatory.
• M.D. or PhD/PharmD with a minimum of 7 years relevant drug development experience with five years in regulatory.
• Strong strategic thinking, problem-solving, and continuous learning mindset.
• Effective communicator—both written and verbal—with the ability to influence, lead, and negotiate across levels and functions.

Responsibilities

• Develops worldwide regulatory strategies to optimize labeling and obtain shortest time to approval by regulatory agencies.
• Provides expert regulatory advice as the Global Regulatory Lead to Product Development Teams and regulatory single point-of-contact for developmental compounds or marketed products throughout the entire product life cycle.
• Leads cross-functional efforts to prepare for FDA advisory committees, as applicable.
• Coordinates the preparation, submission and follow-up communications with regulatory agencies and is responsible for regulatory review of global applications and associated documentation.
• Interacts independently with regulatory agencies (FDA, EMA), including leading regulatory meetings, teleconferences, and written communications.
• Reviews Worldwide Marketing Applications, Clinical Study Reports, protocols, Investigator Brochures.

Skills

Drug Development

Global Regulatory

Pharmaceutical Industry

Regulatory Submissions

Regulatory Strategy

Regulatory Affairs Management

Regulatory Communications

Regulatory Documents

Strategic Leadership

Education

B.S./M.S.

M.D./Ph.D./PharmD

Job description

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

This role serves as the global regulatory lead on complex programs, guiding labeling, submissions, and agency interactions across multiple markets. The ideal candidate brings senior-level regulatory expertise, strategic leadership, and experience with major health authorities (FDA/EMA), and a track record of speeding time to