Global Regulatory Lead, Immunology (Remote)

Merck; Concord (NH); Remote; USD 191,000 - 300,000; Full time

Benefits offered by this job

Annual bonus

Long-term incentive

Comprehensive benefits package

Job summary

Merck seeks a Senior Director (Sr. Principal Scientist), Regulatory Affairs Liaison, to lead worldwide regulatory strategies for General Medicine Immunology programs.

You will act as global regulatory lead on project teams, coordinating with FDA/EMA and subsidiaries to optimize labeling and accelerate approvals. The role requires strategic leadership, proactive management of complex programs, and strong experience with major Health Authorities.

Qualifications

• Strong strategic thinking and problem-solving mindset.
• Effective written and verbal communicator with influence across levels.
• Experience interacting with major Health Authorities (FDA, EMA).
• Demonstrated global regulatory leadership across major markets (US, EU, etc.).
• Leadership of cross-functional regulatory teams throughout product life cycle.

Responsibilities

• Develops worldwide regulatory strategies to optimize labeling and shorten approval timelines.
• Leads regulatory teams and serves as global single point of contact for development programs.
• Interacts with regulatory agencies, leading meetings and written communications.
• Prepares and submits global regulatory documentation and manages lifecycle activities.
• Guides preparation for advisory committees and regulatory due diligence activities.

Skills

Regulatory Strategy

Global Regulatory

Health Authority Liaison

Strategic Leadership

Regulatory Submissions

Education

BS/MS in life sciences

MD/PhD/PharmD

Job description

Merck seeks a Senior Director (Sr. Principal Scientist), Regulatory Affairs Liaison, to lead worldwide regulatory strategies for General Medicine Immunology programs.

You will act as global regulatory lead on project teams, coordinating with FDA/EMA and subsidiaries to optimize labeling and accelerate approvals. The role requires strategic leadership, proactive management of complex programs, and strong experience with major Health Authorities.