Global Regulatory Leader - Immunology (Remote)

Merck; Olympia (WA); Remote; USD 173.000 - 273.000; Vollzeit

Zusammenfassung

Merck in Rahway, NJ seeks a Director (Principal Scientist), Global Regulatory Liaison to lead worldwide regulatory strategies for Immunology projects, coordinating with FDA/EMA and cross-functional teams.

The role requires independent management of complex programs, with leadership across multiple indications and submissions; a proven track record in regulatory filings is essential. This remote-friendly senior position offers a competitive salary and benefits.

Qualifikationen

• B.S. or M.S. with 7+ years in drug development, regulatory focus
• M.D./PhD/PharmD with 5+ years in drug development, 3+ in regulatory
• Strong strategic thinking and problem-solving mindset
• Excellent written and verbal communication to influence and negotiate
• Experience with health authorities (FDA/EMA) interactions
• Experience leading regulatory filings across global regions

Aufgaben

• Develop worldwide regulatory strategies to optimize labeling and speed approvals
• Coordinate preparation, submission and follow-up with regulatory agencies
• Provide leadership to the Global Regulatory Team across development programs
• Interact with regulatory agencies (FDA, EMA) including meetings and communications
• Review marketing applications, study reports, protocols, and Investigator Brochures
• Prepare IND/CTAs for global studies

Kenntnisse

Strategic thinking

Regulatory strategy

Regulatory submissions

Global regulatory

Stakeholder leadership

FDA/EMA interaction

Regulatory communications

Immunology knowledge

Ausbildung

B.S./M.S in related field

M.D./PhD/PharmD

Jobbeschreibung

Merck in Rahway, NJ seeks a Director (Principal Scientist), Global Regulatory Liaison to lead worldwide regulatory strategies for Immunology projects, coordinating with FDA/EMA and cross-functional teams.

The role requires independent management of complex programs, with leadership across multiple indications and submissions; a proven track record in regulatory filings is essential. This remote-friendly senior position offers a competitive salary and benefits.