Global Regulatory Lead, Immunology

HireLifeScience; Rahway (NJ); Remote; USD 173,000 - 273,000; Full time

Job summary

HireLifeScience seeks a Director (Principal Scientist), Global Regulatory Liaison to lead worldwide regulatory strategies in Immunology. You will be the global point of contact on assigned projects, interacting with FDA, EMA, and affiliates to optimize labeling and shorten approval timelines.

The role requires independent project management, strategic thinking, and strong communication. Immunology experience is strongly preferred and travel is expected.

Qualifications

• Strong strategic thinking and problem-solving abilities for regulatory programs.
• Excellent written and verbal communication across levels and functions.
• Experience leading interactions with major health authorities (FDA, EMA).

Responsibilities

• Develops global regulatory strategies to optimize labeling and approval timelines.
• Provides expert Regulatory Lead input to Development Teams and serves as global POC.
• Leads cross-functional Global Regulatory Team coordination for development programs.
• Coordinates regulatory submissions and liaises with regulatory agencies and affiliates.

Skills

Strategic thinking

Problem-solving

Continuous learning

Effective communication

Regulatory leadership

Education

B.S./M.S. in life sciences or related field

M.D./Ph.D./PharmD in relevant area

Job description

HireLifeScience seeks a Director (Principal Scientist), Global Regulatory Liaison to lead worldwide regulatory strategies in Immunology. You will be the global point of contact on assigned projects, interacting with FDA, EMA, and affiliates to optimize labeling and shorten approval timelines.

The role requires independent project management, strategic thinking, and strong communication. Immunology experience is strongly preferred and travel is expected.