Remote Global Regulatory Lead, Immunology

Merck

Springfield (IL)

Remote

USD 173,000 - 273,000

Full time

6 days ago

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Job summary

Merck is seeking a Director (Principal Scientist), Global Regulatory Liaison, to lead worldwide regulatory strategies for Immunology projects. The role operates as the single global contact on teams, interacts with FDA/EMA and other health authorities, and directs cross-functional regulatory support across development and lifecycle management.

The candidate should have senior-level experience in regulatory affairs, strong strategic thinking, and proven communication and negotiation skills to

Qualifications

Minimum education: BS/MS with 7+ years drug development experience in regulatory.
MD/PhD/PharmD with 5+ years regulatory experience required.
Experience interacting with major Health Authorities (FDA, EMA).

Responsibilities

Develops worldwide regulatory strategies to optimize labeling and approvals.
Lead regulatory filings across global regions and coordinate with teams.
Interact with regulatory agencies and regional affiliates on strategy and submissions.
Provide leadership to cross-functional regulatory teams and ensure lifecycle support.

Skills

Drug Development

Global Regulatory

Pharmaceutical Industry

Pharmaceutical Research

Product Registrations

Regulatory Affairs Management

Regulatory Communications

Regulatory Processes

Regulatory Strategies

Regulatory Submissions

Strategic Leadership

Education

Bachelor's or Master's degree in a relevant field

MD/PhD/PharmD with regulatory experience

Job description

The candidate should have senior-level experience in regulatory affairs, strong strategic thinking, and proven communication and negotiation skills to

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