Global Regulatory Leader, Immunology (Remote)

Merck; Trenton (NJ); Remote; USD 173.000 - 273.000; Vollzeit

Benefits dieser Stelle

Annual bonus

401(k) retirement plan

Medical, dental, vision insurance

Zusammenfassung

Merck in the United States seeks a Director (Principal Scientist), Global Regulatory Liaison to lead worldwide regulatory strategies for Immunology programs and to optimize labeling and time to approval. This role acts as the global single point of contact on regulatory issues, guiding development teams and external partnerships through the life cycle of drugs/biologics.

The candidate will interact with FDA/EMA, coordinate regional strategies with RA Europe and affiliates, and provide leadership

Qualifikationen

• B.S. or M.S with 7+ years in drug development, regulatory focus.
• M.D./PhD/PharmD with 5+ years in drug development and 3+ years in regulatory.
• Strong strategic thinking, communication, and leadership for cross-functional teams.
• Experience interacting with major Health Authorities (FDA, EMA).

Aufgaben

• Develop worldwide regulatory strategies to optimize labeling and approvals.
• Lead global regulatory programs across indications and products.
• Coordinate submissions and interactions with regulatory agencies.
• Provide leadership to Global Regulatory Team and cross-functional support.
• Interact independently with regulatory agencies (FDA, EMA) and regional bodies.

Kenntnisse

Drug Development

Global Regulatory

Regulatory Affairs Management

Regulatory Submissions

Regulatory Strategies

Regulatory Communications

Strategic Leadership

Pharmaceutical Industry

Product Registrations

Ausbildung

B.S. or M.S with 7+ years in drug development

M.D./PhD/PharmD with 5+ years in regulatory

Jobbeschreibung

Merck in the United States seeks a Director (Principal Scientist), Global Regulatory Liaison to lead worldwide regulatory strategies for Immunology programs and to optimize labeling and time to approval. This role acts as the global single point of contact on regulatory issues, guiding development teams and external partnerships through the life cycle of drugs/biologics.

The candidate will interact with FDA/EMA, coordinate regional strategies with RA Europe and affiliates, and provide leadership