Regulatory CMC Biologics Lead - Associate Principal

MSD Malaysia; Northern (KY); Hybrid; USD 142,000 - 224,000; Full time

Benefits offered by this job

Medical, dental, vision coverage

401(k) and retirement benefits

Paid holidays and vacation

Job summary

Merck & Co., Inc. seeks an Associate Principal Scientist, Regulatory CMC - Biologics (R4) to lead global CMC regulatory strategies. You will prepare and submit CMC sections for biologics, mentor junior staff, and collaborate across functional areas to ensure timely submissions.

You will contribute to IND/BLA filings, post-approval changes, and cross-functional regulatory programs, ensuring scientific rigor and regulatory compliance within a biotech environment.

Qualifications

• Prior biologics IND, BLA, or post-approval filing experience with 10+ years in biologics CMC.
• Experience with regulatory interactions and responses to questions for IND/BLA.
• Understanding of manufacturing, analytics, and quality in biologics.

Responsibilities

• Lead global regulatory strategies for submission and approval of biologics CMC content.
• Author and review Clinical Trial Applications, INDs, BLAs, and post-approval documents.
• Collaborate with cross-functional teams to ensure submission quality and timelines.
• Mentor scientists, escalate issues to CMC leadership, and support development programs.

Skills

CMC regulatory strategy

Biologics development

IND/BLA experience

Regulatory writing

Regulatory submissions

Project leadership

Cross-functional collaboration

Education

Bachelor's degree in science or related field

Advanced degree preferred

Tools

eCTD

Job description

Merck & Co., Inc. seeks an Associate Principal Scientist, Regulatory CMC - Biologics (R4) to lead global CMC regulatory strategies. You will prepare and submit CMC sections for biologics, mentor junior staff, and collaborate across functional areas to ensure timely submissions.

You will contribute to IND/BLA filings, post-approval changes, and cross-functional regulatory programs, ensuring scientific rigor and regulatory compliance within a biotech environment.