Global Regulatory Lead, Immunology - Remote

Merck; Lansing (MI); Remote; USD 173,000 - 273,000; Full time

Benefits offered by this job

Medical, dental, vision benefits

401(k) retirement benefits

Job summary

Merck is seeking a Director (Principal Scientist), Global Regulatory Liaison to lead worldwide regulatory strategies for Immunology programs and to act as the global point-of-contact for development teams and regulatory authorities.

The role requires senior experience in regulatory filings across global regions, strong leadership, and the ability to drive labeling optimization and time-to-approval for multiple indications and partners.

Qualifications

• B.S. or M.S with a minimum of 7 years of relevant drug development experience with majority in regulatory
• 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 and provides final approval of local registration study protocols when needed to obtain marketing authorization in secondary markets
• Interact independently with regulatory agencies (FDA, EMA, etc.), 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

Strategic thinking

Communication

Regulatory interactions with Health Ld

Regulatory filings

Global regulatory

Drug development

Regulatory affairs management

Regulatory processes

Regulatory strategies

Regulatory submissions

Strategic leadership

Education

B.S. or M.S.

M.D. or PhD/PharmD

Tools

None

Job description

Merck is seeking a Director (Principal Scientist), Global Regulatory Liaison to lead worldwide regulatory strategies for Immunology programs and to act as the global point-of-contact for development teams and regulatory authorities.

The role requires senior experience in regulatory filings across global regions, strong leadership, and the ability to drive labeling optimization and time-to-approval for multiple indications and partners.