Biologics Regulatory CMC Lead

Caraway Therapeutics, Inc.; United States; Hybrid; USD 142,000 - 224,000; Full time

Benefits offered by this job

Medical, dental, vision

401(k)

Job summary

Merck & Co., Inc. in Rahway, NJ invites an Associate Principal Scientist, Regulatory CMC - Biologics (R4) to lead global regulatory strategies for biologics, including IND/BLA submissions. The role requires 10+ years of biologics CMC experience and strong leadership.

Hybrid work arrangements are available with a competitive salary range and comprehensive benefits. The position offers a pathway toward Associate Director responsibilities and is based in the United States.

Qualifications

• 10+ years of biologics CMC regulatory experience including IND/BLA submissions.
• Experience drafting and submitting global regulatory documents across regions.
• Strong communication and leadership in cross-functional teams.

Responsibilities

• Lead authoring of CMC submissions for INDs, BLAs, and post-approval changes.
• Develop and implement global regulatory strategies for submission and approval of biologics.
• Coordinate submissions and communicate timelines to support continued product supply.
• Collaborate with cross-functional teams to ensure accuracy and completeness of submissions.
• Mentor junior scientists in assigned projects.

Skills

Regulatory strategy

CMC development

IND/BLA experience

Global submissions

Leadership

Education

Bachelor's degree in science/engineering

Tools

eCTD

Job description

Merck & Co., Inc. in Rahway, NJ invites an Associate Principal Scientist, Regulatory CMC - Biologics (R4) to lead global regulatory strategies for biologics, including IND/BLA submissions. The role requires 10+ years of biologics CMC experience and strong leadership.

Hybrid work arrangements are available with a competitive salary range and comprehensive benefits. The position offers a pathway toward Associate Director responsibilities and is based in the United States.