Principal Scientist, Regulatory Liaison - Immunology
Merck · Rahway, NJ +3 more
The apply link worked recently (not employer-confirmed).
Role summary
Principal Scientist position in regulatory affairs for immunology programs at Merck, responsible for developing global regulatory strategies and serving as the primary regulatory contact for assigned investigational and marketed drugs. The role requires independent project management, engagement with worldwide regulatory agencies, and leadership of cross-functional regulatory teams.
Where this listing comes from
This listing was compiled by RoleLantern from the employer's publicly available posting on Workday, captured and rephrased by RoleLantern using automated (AI) tools on 2026-10-04 (originally posted 2026-10-04). It was not submitted or confirmed by the employer through RoleLantern. Details may be inaccurate, incomplete, outdated, or no longer available; please confirm with the employer's official posting before applying.
What they're looking for
- B.S./M.S. with 7+ years drug development experience, majority in regulatory affairs
- M.D./Ph.D./PharmD with 5+ years drug development experience and 3+ years in regulatory
- Strong strategic thinking, problem-solving, and continuous learning capabilities
- Demonstrated expertise leading regulatory filings across global regions
- Direct experience interacting with major health authorities such as FDA and EMA
- Excellent written and verbal communication with ability to influence across functions
- Immunology therapeutic area expertise preferred
What you'll be doing
- Develop and implement worldwide regulatory strategies to optimize labeling and expedite regulatory approvals
- Serve as global regulatory lead and single point-of-contact for assigned product development teams
- Lead independent interactions with regulatory agencies including FDA and EMA meetings and communications
- Coordinate preparation and submission of regulatory filings and applications with regulatory agencies
- Oversee global regulatory team providing cross-functional support for development and marketed products
Key requirements
- Therapeutic area
- Immunology
Privacy & handoff
This role links to Merck's own application system. RoleLantern records your interest and checks the link, but the application happens on the employer's site and status updates may not come back to us. Clicking apply does not mark you as applied automatically.