Remote Senior Regulatory Lead, Immunology

Merck Group; Rahway, Northern (NJ, KY); Hybrid; USD 191,000 - 300,000; Full time

Job summary

Merck Group is seeking a Senior Director (Sr. Principal Scientist), Regulatory Affairs Liaison to lead worldwide regulatory strategies for General Medicine, with a focus on Immunology. The role emphasizes speed‑to‑market while ensuring compliant labeling and approvals.

The successful candidate will interact with regulatory agencies (FDA, EMA) and guide cross‑functional teams to deliver regulatory submissions and lifecycle activities across global markets, including travel as needed.

Qualifications

• Bachelor's or higher degree in a relevant field with extensive drug development or regulatory experience.
• MD/PhD/PharmD with significant regulatory leadership experience.

Responsibilities

• Develops worldwide regulatory strategies to optimize labeling and shorten approval timelines.
• Leads or supports interactions with major Health Authorities (FDA, EMA).
• Coordinates regulatory submissions, reviews, and communications across global programs.
• Provides strategic regulatory leadership to Product Development Teams and cross‑functional groups.
• Mentors Global Regulatory Team and ensures alignment with company values.

Skills

Drug Development

Global Regulatory

Pharma Industry

Pharmaceutical Research

Product Registrations

Regulatory Affairs

Regulatory Communications

Regulatory Documents

Regulatory Processes

Regulatory Strategies

Regulatory Submissions

Strategic Leadership

Education

B.S. or M.S.

M.D. or PhD/PharmD

Job description

Merck Group is seeking a Senior Director (Sr. Principal Scientist), Regulatory Affairs Liaison to lead worldwide regulatory strategies for General Medicine, with a focus on Immunology. The role emphasizes speed‑to‑market while ensuring compliant labeling and approvals.

The successful candidate will interact with regulatory agencies (FDA, EMA) and guide cross‑functional teams to deliver regulatory submissions and lifecycle activities across global markets, including travel as needed.