Remote Global Regulatory Lead, Immunology

Merck; Honolulu (HI); Remote; USD 173,000 - 273,000; Full time

Benefits offered by this job

Medical, dental, vision insurance

401(k) retirement plan

Paid holidays

Vacation

Sick days

Remote work option

Job summary

Merck is seeking a Director (Principal Scientist), Global Regulatory Liaison to develop and implement worldwide regulatory strategies for Immunology projects. You will be the single global contact for regulatory strategy and oversee submissions, labeling, and approvals across multiple markets.

The role requires leading cross-functional teams, engaging with health authorities, and driving speed-to-market while maintaining compliance.

Qualifications

• BS/MS in a relevant field with 7+ years in drug development or regulatory work.
• MD/PhD/PharmD with 5+ years in regulatory affairs and leadership roles.

Responsibilities

• Develops worldwide regulatory strategies to optimize labeling and approval timelines.
• Leads regulatory interactions with FDA, EMA, and global authorities.
• Provides leadership to the global regulatory team and cross-functional partners.

Skills

Drug Development

Global Regulatory

Regulatory Affairs

Regulatory Submissions

Strategic Leadership

Regulatory Strategy

Education

B.S./M.S.

MD/PhD/PharmD

Job description

Merck is seeking a Director (Principal Scientist), Global Regulatory Liaison to develop and implement worldwide regulatory strategies for Immunology projects. You will be the single global contact for regulatory strategy and oversee submissions, labeling, and approvals across multiple markets.

The role requires leading cross-functional teams, engaging with health authorities, and driving speed-to-market while maintaining compliance.