Principal Scientist (Director) - Regulatory Affairs-CMC

Principal Scientist / Director, Global Regulatory CMC Biologics

Responsibilities:
- Develop and implement Chemistry, Manufacturing, and Controls (CMC) regulatory strategies for biologics product franchises in line with domestic and international regulations.
- Lead preparation and submission of CMC sections for commercial or new biologics products.
- Serve as Regulatory CMC Project Lead; provide CMC regulatory leadership across teams.
- Lead delivery of regulatory milestones (including success probability assessment and risk mitigation).
- Develop, communicate, and review CMC Regulatory Strategy Documents.
- Lead development and execution of global IND/BLA/post-approval change submissions per timelines.
- Manage CMC documentation (IND/CTA, BLA/MAA, post-approval lifecycle), agency background packages, and responses to health authority questions.
- Collaborate on submission reviews; resolve complex issues and recommend next steps to leadership.
- Provide regulatory leadership for in-license/due diligence, divestment, and withdrawal activities.
- Support new technology development; focus on compliance; mentor junior staff as needed.

Qualifications:
- B.S. in biological science, engineering, or related field (advanced degree preferred).
- At least 10 years relevant experience in biologics/vaccine Regulatory CMC or biologics development/manufacturing/testing/licensure.
- Proficient in English; periodic travel may be required.

Preferred:
- Regulatory CMC experience in ADCs.

Benefits: Annual bonus and long-term incentive (if applicable); comprehensive health/retirement/paid time off.

Apply: https://jobs.merck.com/us/en (deadline listed on posting).