Senior Regulatory CMC Scientist (Biologics)

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

Benefits offered by this job

Annual bonus

Long-term incentive

Benefits package

Job summary

Merck in the United States is seeking an Associate Principal Scientist, Regulatory CMC - Biologics (R4). This role oversees global regulatory strategies for biologics CMC, prepares and submits CMC sections, and mentors scientists on regulatory content.

The position requires at least 10 years of biologics IND/BLA/post-approval experience, strong leadership, and collaboration across cross-functional teams to ensure timely submissions and product supply.

Qualifications

• IND/BLA and post-approval filing experience in biologics (10+ years).
• Experience in biologics regulatory CMC for pre-approval and registration.
• Understanding of manufacturing, process development, analytical, and QA.
• Strong written and verbal communication across multicultural stakeholders.
• Ability to lead, manage projects and resolve issues with leadership escalation.

Responsibilities

• Lead the development and execution of global regulatory CMC strategies for biologics.
• Prepare and submit CMC sections for commercial or new biologics products.
• Mentor Senior Scientist/Scientist in regulatory content and submissions.
• Author and coordinate Clinical Trial Applications, INDs, BLAs, and post-approval submissions.
• Collaborate with partner teams to ensure compliance and completeness of submissions.
• Track submissions and communicate timelines to support continued supply.
• Engage with CMC leadership to resolve issues and optimize processes.

Skills

Regulatory Writing

Regulatory Submissions

Regulatory Strategy Development

Biologics

IND/BLAs experience

Education

B.S. in Science/Engineering

Tools

eCTD

Job description

Merck in the United States is seeking an Associate Principal Scientist, Regulatory CMC - Biologics (R4). This role oversees global regulatory strategies for biologics CMC, prepares and submits CMC sections, and mentors scientists on regulatory content.

The position requires at least 10 years of biologics IND/BLA/post-approval experience, strong leadership, and collaboration across cross-functional teams to ensure timely submissions and product supply.