Senior Director (Sr Principal Scientist), Regulatory Liaison

Senior Principal Scientist in Regulatory Affairs at Merck responsible for developing and implementing worldwide regulatory strategies for General Medicine and Immunology programs. The role involves independent project management, direct agency interactions, and leadership of regulatory teams to optimize labeling and accelerate product approvals.

Responsibilities

• Develop worldwide regulatory strategies to optimize product labeling and accelerate time to approval
• Serve as global regulatory lead and single point-of-contact for assigned investigational and marketed products
• Lead cross-functional regulatory teams coordinating support for development programs and marketed products
• Independently coordinate with regulatory agencies including FDA and EMA on submissions and strategy discussions
• Prepare IND/CTAs, clinical study reports, protocols, and worldwide marketing applications for regulatory review

Requirements

• B.S. or M.S. with 10+ years drug development experience, majority in regulatory affairs
• M.D., PhD, or PharmD with 7+ years drug development and 5+ years regulatory experience
• Strong strategic thinking, problem-solving, and continuous learning capability
• Direct interaction experience with FDA, EMA, and other major health authorities
• Demonstrated expertise leading regulatory strategies across global regions and markets
• Leadership experience building and managing high-performing teams or complex projects
• Immunology therapeutic area expertise strongly preferred

Compensation: $190,800–$300,300 base