Global Regulatory Strategy Director — Immunology (Remote)

Merck; Cheyenne (WY); Remote; USD 173.000 - 273.000; Vollzeit

Zusammenfassung

Merck is seeking a Director (Principal Scientist), Global Regulatory Liaison who will lead worldwide regulatory strategies and oversee regulatory activities for Immunology programs from early development through life cycle. This role serves as the global single point of contact with agencies like FDA/EMA and partners to ensure optimal labeling and rapid approvals.

You will manage cross-functional teams, coordinate submissions, and guide regulatory strategy across multiple indications and

Qualifikationen

• BS/MS with 7+ years in drug development, majority in regulatory.
• MD/PhD/PharmD with 5+ years drug regulatory experience.
• Strong strategic thinking and problem-solving mindset.
• Effective written and verbal communicator with cross-functional influence.
• Experience interacting with major Health Authorities (FDA, EMA).
• Demonstrated leadership in regulatory filings across global regions.
• Immunology experience preferred; broad regulatory knowledge across major markets.

Aufgaben

• Develops worldwide regulatory strategies to optimize labeling and accelerate approvals.
• Assesses regulatory landscape to set global strategies enabling speed-to-market and target labeling.
• Acts as Global Regulatory Lead to Product Development Teams and regulatory single point of contact.
• Leads the Global Regulatory Team coordinating cross-functional regulatory support for programs.
• Coordinates preparation, submission, and follow-up with regulatory agencies and subsidiaries.

Jobbeschreibung

Merck is seeking a Director (Principal Scientist), Global Regulatory Liaison who will lead worldwide regulatory strategies and oversee regulatory activities for Immunology programs from early development through life cycle. This role serves as the global single point of contact with agencies like FDA/EMA and partners to ensure optimal labeling and rapid approvals.

You will manage cross-functional teams, coordinate submissions, and guide regulatory strategy across multiple indications and