Global Regulatory Liaison Director, Immunology (Remote)

Merck; Trenton (NJ); À distance; USD 173 000 - 273 000; Plein temps

Résumé du poste

Merck seeks a Director (Principal Scientist), Global Regulatory Liaison to design and drive worldwide regulatory strategies for Immunology programs. The role leads cross-functional teams, manages global submissions, and serves as the primary regulatory contact for projects across life-cycle stages, including interactions with FDA/EMA.

The position emphasizes proactive leadership, strategic thinking, and strong communication to accelerate approvals while ensuring compliant labeling and regulatory

Qualifications

• B.S./M.S with 7+ years in regulatory drug development, majority in regulatory.
• M.D./PhD/PharmD with 5+ years of drug development experience, 3+ years in regulatory.
• Strong strategic thinking, problem-solving and communication skills.

Responsabilités

• Develops worldwide regulatory strategies to optimize labeling and time-to-approval.
• Lead regulatory teams and act as global single point of contact for projects.
• Interact with FDA, EMA and other authorities; coordinate regional strategy with RA Europe.
• Coordinate submissions, reviews, and regulatory documentation across life cycle.
• Review study protocols for regulatory approvals in secondary markets.
• Lead or support direct interactions with health authorities and provide expert advice.
• Provide leadership to cross-functional teams and ensure regulatory alignment.

Connaissances

Drug Development

Global Regulatory

Regulatory Submissions

Regulatory Communications

Regulatory Processes

Regulatory Affairs

Product Registrations

Strategic Leadership

Pharmaceutical Industry

Pharmaceutical Research

Immunology

Formation

B.S. or M.S with 7+ years regulatory drug development experience

M.D. or PhD/PharmD with 5+ years regulatory experience (3 in regulatory)

Description du poste

Merck seeks a Director (Principal Scientist), Global Regulatory Liaison to design and drive worldwide regulatory strategies for Immunology programs. The role leads cross-functional teams, manages global submissions, and serves as the primary regulatory contact for projects across life-cycle stages, including interactions with FDA/EMA.

The position emphasizes proactive leadership, strategic thinking, and strong communication to accelerate approvals while ensuring compliant labeling and regulatory