Global Regulatory Lead, Immunology (Remote)

Merck; Phoenix (AZ); 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, coordinate with FDA/EMA, and drive labeling optimization and fastest possible approvals.

The role requires independent project management, leadership of the regulatory team, and collaboration with development teams and external partners, with strong immunology experience preferred.

Qualifications

• Bachelor's or higher degree in a relevant field with 7+ years of drug development experience in regulatory.
• M.D./Ph.D./PharmD with 5+ years regulatory experience, including major health authorities interactions.

Responsibilities

• Develops worldwide regulatory strategies to optimize labeling and approval timelines.
• Lead/regulatory single point of contact for projects; interact with global agencies and affiliates.

Skills

Global Regulatory

Regulatory Strategy

Regulatory Submissions

Leadership

Strategic thinking

Education

B.S./M.S in a relevant field

M.D./PhD/PharmD in a relevant field

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, coordinate with FDA/EMA, and drive labeling optimization and fastest possible approvals.

The role requires independent project management, leadership of the regulatory team, and collaboration with development teams and external partners, with strong immunology experience preferred.