Senior Global Regulatory Lead, Immunology

Caraway Therapeutics, Inc.; Rahway (NJ); Remote; USD 191,000 - 300,000; Full time

Job summary

Merck & Co., Inc. in Rahway, NJ seeks a Senior Director of Regulatory Affairs Liaison to develop and implement worldwide regulatory strategies for General Medicine projects, with a focus on Immunology.

The role emphasizes independence, strategic leadership, and global regulatory oversight across product life cycles. The candidate should lead interactions with major Health Authorities (FDA, EMA) and coordinate cross-functional teams to optimize labeling and speed approvals, while ensuring

Qualifications

• B.S. or M.S with substantial drug development experience in regulatory.
• M.D. or PhD/PharmD with extensive regulatory experience is preferred.

Responsibilities

• Develops worldwide regulatory strategies to optimize labeling and approval timelines.
• Leads global regulatory teams and serves as global regulatory lead for development programs.
• Interacts with FDA, EMA, and other authorities; leads regulatory meetings and communications.
• Reviews regulatory documentation including INDs/CTAs, CSRs, and protocols.
• Coordinates regulatory submissions and post-submission activities across regions.

Skills

Regulatory Strategy

Global Regulatory

Health Authorities

Project Leadership

Regulatory Submissions

Education

Bachelor/Master degree

MD/PhD/PharmD

Job description

Merck & Co., Inc. in Rahway, NJ seeks a Senior Director of Regulatory Affairs Liaison to develop and implement worldwide regulatory strategies for General Medicine projects, with a focus on Immunology.

The role emphasizes independence, strategic leadership, and global regulatory oversight across product life cycles. The candidate should lead interactions with major Health Authorities (FDA, EMA) and coordinate cross-functional teams to optimize labeling and speed approvals, while ensuring