Global Regulatory Strategy Director, Immunology | Remote

Merck; Juneau (AK); Remote; USD 173,000 - 273,000; Full time

Benefits offered by this job

Annual bonus

Long-term incentive

Comprehensive benefits

Job summary

Merck in Rahway, USA seeks a Director (Principal Scientist), Global Regulatory Liaison to develop and implement worldwide regulatory strategies for Immunology projects, overseeing labeling optimization and fastest possible approvals by global agencies.

You will manage global programs as single accountable contact, lead cross-functional regulatory teams, coordinate INDs/CTAs, liaise with FDA/EMA, and drive submissions across regions, including major markets, with preferred Immunology background.

Qualifications

• BS/MS with 7+ years in drug development with regulatory focus.
• MD/PhD/PharmD with 5+ years in drug development and at least 3 years regulatory work.
• Experience leading regulatory filings across global regions.

Responsibilities

• Develop worldwide regulatory strategies to optimize labeling and speed approvals.
• Coordinate regulatory submissions (INDs/CTAs) for global studies.
• Provide expert regulatory guidance to Product Development Teams and act as single global contact.
• Lead Global Regulatory Team and coordinate cross-functional regulatory support.
• Review and approve local registration study protocols for marketing authorization where needed.
• Interact with regulatory agencies (FDA, EMA) and regional affiliates; lead meetings and communications.

Skills

Regulatory Strategy

Regulatory Submissions

Strategic Leadership

Cross-functional Leadership

Immunology

FDA/EMA interactions

Education

BS/MS in relevant field

MD/PhD/PharmD with regulatory exp

Job description

Merck in Rahway, USA seeks a Director (Principal Scientist), Global Regulatory Liaison to develop and implement worldwide regulatory strategies for Immunology projects, overseeing labeling optimization and fastest possible approvals by global agencies.

You will manage global programs as single accountable contact, lead cross-functional regulatory teams, coordinate INDs/CTAs, liaise with FDA/EMA, and drive submissions across regions, including major markets, with preferred Immunology background.