Regulatory CMC Biologics — Associate Principal Scientist

HireLifeScience; Rahway (NJ); Hybrid; USD 142,000 - 224,000; Full time

Job summary

Merck is seeking an Associate Principal Scientist, Regulatory CMC - Biologics (R4) in a role equivalent to Associate Director. You will lead global CMC regulatory strategies, prepare submissions, and mentor teams to ensure timely compliance with IND/BLA post-approval requirements.

The position emphasizes leadership, cross-functional collaboration, and expert regulatory writing for clinical and commercial biologics, with hybrid work options and US-based responsibilities.

Qualifications

• Minimum of a science/engineering BS; advanced degree preferred.
• 10+ years of biologics regulatory CMC experience including IND, BLA, and post-approval filings.
• Strong ability to lead authoring and cross-functional collaboration for regulatory submissions.

Responsibilities

• Lead regulatory strategies for biologics CMC to meet global requirements.
• Prepare and submit CMC sections for commercial or new biologics products.
• Mentor Senior Scientist / Scientist and drive timelines for submissions.

Skills

Regulatory strategy

Regulatory writing

Regulatory submissions

Leadership

Cross-cultural communication

Project management

Biologics knowledge

IND/BLA experience

Analytical thinking

Communication

Education

Bachelor's degree in science/engineering

Advanced degree preferred

Tools

eCTD

Job description

Merck is seeking an Associate Principal Scientist, Regulatory CMC - Biologics (R4) in a role equivalent to Associate Director. You will lead global CMC regulatory strategies, prepare submissions, and mentor teams to ensure timely compliance with IND/BLA post-approval requirements.

The position emphasizes leadership, cross-functional collaboration, and expert regulatory writing for clinical and commercial biologics, with hybrid work options and US-based responsibilities.