Principal Scientist, Regulatory Liaison - Immunology

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.

Responsibilities

• 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

Requirements

• 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

Compensation: $173,200-$272,600 base