Global Regulatory Lead - Immunology (Remote)

HireLifeScience; Boston (MA); Remote; USD 173,000 - 273,000; Full time

Job summary

Merck seeks a Director (Principal Scientist), Global Regulatory Liaison to lead worldwide regulatory strategies for Immunology programs. You will act as the global point of contact on regulatory strategy, coordinating with FDA, EMA and affiliates to accelerate approvals and optimize labeling.

You will manage cross-functional teams, review regulatory documents, and lead submissions across regions, with a focus on speed-to-market and strategic risk management. Remote-friendly role.

Qualifications

• Minimum education: B.S. or M.S. with 7+ years in drug development/regulatory, or M.D./PhD/PharmD with 5+ years regulatory experience.
• Proven ability to lead regulatory filings and interact with major Health Authorities (FDA, EMA).
• Strong strategic thinking, problem-solving, and cross-functional leadership capabilities.
• Excellent written and verbal communication to influence and negotiate across levels.

Responsibilities

• Develops worldwide regulatory strategies to optimize labeling and accelerate approvals by global agencies.
• Coordinates submissions and communications with regulatory agencies and subsidiaries across regions.
• Leads the Global Regulatory Team and serves as the single point of contact for development programs.
• Interacts with FDA, EMA and other agencies; leads or supports regulatory filings across global regions.
• Reviews regulatory documentation (e.g., study reports, protocols) for marketing authorization in multiple markets.

Job description

Merck seeks a Director (Principal Scientist), Global Regulatory Liaison to lead worldwide regulatory strategies for Immunology programs. You will act as the global point of contact on regulatory strategy, coordinating with FDA, EMA and affiliates to accelerate approvals and optimize labeling.

You will manage cross-functional teams, review regulatory documents, and lead submissions across regions, with a focus on speed-to-market and strategic risk management. Remote-friendly role.