Global Regulatory Lead, Immunology (Remote)

Merck; Frankfort (KY); Remote; USD 191,000 - 300,000; Full time

Benefits offered by this job

Annual bonus

Long-term incentive

Remote work

Comprehensive benefits

Job summary

Merck seeks a Senior Director, Regulatory Affairs Liaison, to lead global regulatory strategies for Immunology programs and act as the single accountable point of contact for development and marketed products across multiple indications. You will interact with FDA, EMA, and other agencies to optimize labeling and speed to approval.

The role requires strategic thinking, independent project management, and leadership of cross-functional teams.

Qualifications

• Must have deep experience in global regulatory planning and submissions.
• Experience leading regulatory strategies across multiple geographies.

Responsibilities

• Develops worldwide regulatory strategies to optimize timelines and labeling.
• Leads interactions with major Health Authorities (FDA, EMA) and regulatory meetings.
• Coordinates preparation and submission of global regulatory dossiers and CTAs/INDs.
• Provides regulatory leadership to Product Development Teams and cross-functional groups.

Skills

Regulatory strategy

Global regulatory

FDA interactions

EMA interactions

Leadership

Education

Bachelor's or higher in life sciences

MD/PhD in related field

Job description

Merck seeks a Senior Director, Regulatory Affairs Liaison, to lead global regulatory strategies for Immunology programs and act as the single accountable point of contact for development and marketed products across multiple indications. You will interact with FDA, EMA, and other agencies to optimize labeling and speed to approval.

The role requires strategic thinking, independent project management, and leadership of cross-functional teams.