Global Regulatory Lead - Immunology (Remote)

Merck; Madison (WI); Remote; USD 191,000 - 300,000; Full time

Benefits offered by this job

Remote work

Medical, dental, vision insurance

401(k) retirement plan

Paid holidays and vacation

Annual bonus & long-term incentive

Job summary

Merck & Co., Inc. is seeking a Senior Director, Regulatory Affairs Liaison to drive worldwide regulatory strategies for General Medicine immunology programs and to guide complex global submissions.

You will act as the single accountable contact on project teams, interact with global health authorities, lead regulatory meetings, and coordinate cross‑functional teams through lifecycle regulatory activities across major markets.

Qualifications

• Bachelor's or higher degree with extensive drug development experience in regulatory.
• M.D. or PhD/PharmD with substantial regulatory experience preferred.

Responsibilities

• Develops worldwide regulatory strategies to optimize labeling and approval timelines.
• Leads regulatory meetings with FDA, EMA and other authorities.
• Provides strategic regulatory leadership to cross‑functional Product Development Teams.
• Manages global regulatory submissions and lifecycle activities across markets.

Skills

Drug Development

Global Regulatory

Pharmaceutical Industry

Pharmaceutical Research

Product Registrations

Regulatory Affairs Management

Regulatory Communications

Regulatory Documents

Regulatory Processes

Regulatory Strategies

Regulatory Strategy Development

Regulatory Submissions

Strategic Leadership

Education

B.S. or M.S.

M.D. or PhD/PharmD

Job description

Merck & Co., Inc. is seeking a Senior Director, Regulatory Affairs Liaison to drive worldwide regulatory strategies for General Medicine immunology programs and to guide complex global submissions.

You will act as the single accountable contact on project teams, interact with global health authorities, lead regulatory meetings, and coordinate cross‑functional teams through lifecycle regulatory activities across major markets.