Remote Global Immunology Regulatory Lead

Merck; Providence (RI); Remote; USD 173,000 - 273,000; Full time

Benefits offered by this job

Medical insurance

Dental insurance

Vision care

Retirement benefits (401k)

Job summary

Merck is seeking a Director (Principal Scientist), Global Regulatory Liaison to drive worldwide regulatory strategies for Immunology programs. You will optimize labeling and accelerate approvals, coordinating with FDA/EMA as the global lead for assigned projects.

You will guide cross-functional teams, manage regulatory submissions across regions, and communicate regulatory expectations to development partners throughout the lifecycle of the drug.

Qualifications

• B.S. or M.S with a minimum of 7 years of relevant drug development experience with majority in regulatory or
• M.D. or PhD/PharmD with a minimum of 5 years relevant drug development experience with three years in regulatory

Responsibilities

• Develops worldwide product regulatory strategies to optimize labeling and obtain shortest time to approval by regulatory agencies for assigned indications
• Assesses regulatory/competitive landscape to establish global regulatory strategies that facilitate speed-to-market and the delivery of targeted product labeling
• Provides expert advice as the Global Regulatory Lead to Product Development Teams and regulatory single point-of-contact for products within and external to GRACS on regulatory issues as they arise with the developmental compounds or marketed products throughout the entire life cycle of the drug
• Provides leadership to the Global Regulatory Team which coordinates cross-functional regulatory support for development programs and marketed products
• Coordinates the preparation, submission and follow-up contact with regulatory agencies and/or subsidiaries for all applications and submissions and responsible for regulatory review and final approval for all submissions and associated documentation.
• Reviews Worldwide Marketing Applications, Clinical Study Reports, protocols, Investigator Brochures
• Prepares IND/CTAs for global studies related to investigational drugs/biologics
• Participates in regulatory due diligence activities for licensing candidate reviews
• Interacts independently with regulatory agencies (FDA, EMA), including leading meetings, teleconferences, and written communications
• Coordinate regional regulatory strategy and submissions through collaboration with Regulatory Affairs Europe (RAE) and local affiliate teams.
• Reviews Worldwide Marketing Applications, Clinical Study Reports, protocols, Investigator Brochures
• Prepares IND/CTAs for global studies related to investigational drugs/biologics
• Participates in regulatory due diligence activities for licensing candidate reviews

Skills

Global Regulatory

Regulatory Strategy

Regulatory Submissions

Cross-functional Leadership

Lifecycle Regulation

FDA/EMA Interactions

Education

B.S./M.S. in science

MD/PhD/PharmD in related field

Job description

Merck is seeking a Director (Principal Scientist), Global Regulatory Liaison to drive worldwide regulatory strategies for Immunology programs. You will optimize labeling and accelerate approvals, coordinating with FDA/EMA as the global lead for assigned projects.

You will guide cross-functional teams, manage regulatory submissions across regions, and communicate regulatory expectations to development partners throughout the lifecycle of the drug.