Director, Global Regulatory Strategy (Immunology)

Merck; Helena (MT); À distance; USD 173 000 - 273 000; Plein temps

Résumé du poste

Merck is seeking a Director (Principal Scientist), Global Regulatory Liaison to develop and implement global regulatory strategies for Immunology programs. You will lead cross-functional teams, engage with global authorities, and drive filings to optimize labeling and time-to-approval across indications.

The role requires strategic leadership, deep regulatory expertise, and collaboration with RA Europe and affiliates to ensure robust regulatory submissions worldwide.

Qualifications

• Minimum 7 years in drug development with regulatory focus.
• Pharma/biotech regulatory leadership experience.
• Experience with major Health Authorities (FDA, EMA).

Responsabilités

• Develops worldwide regulatory strategies to optimize labeling and shorten approval timelines.
• Leads global regulatory initiatives across projects and life-cycle.
• Interacts with regulatory agencies (FDA/EMA) and coordinates submissions.
• Provides leadership to cross-functional regulatory teams and external partners.
• Reviews and approves local and global regulatory documentation and filings.
• Aligns regulatory strategy with product development goals across indications.

Connaissances

Drug Development

Global Regulatory

Pharmaceutical Industry

Pharmaceutical Research

Product Registrations

Regulatory Affairs Management

Regulatory Communications

Regulatory Processes

Regulatory Strategies

Regulatory Submissions

Strategic Leadership

Immunology

Formation

B.S. or M.S. in related field

M.D. or PhD/PharmD

Description du poste

Merck is seeking a Director (Principal Scientist), Global Regulatory Liaison to develop and implement global regulatory strategies for Immunology programs. You will lead cross-functional teams, engage with global authorities, and drive filings to optimize labeling and time-to-approval across indications.

The role requires strategic leadership, deep regulatory expertise, and collaboration with RA Europe and affiliates to ensure robust regulatory submissions worldwide.