Principal Scientist (Director) - Regulatory Affairs-CMC
Merck
July 02, 2026
Remote friendly (Cambridge, MA)
United States
Corporate Functions
Principal Scientist / Director, GLOBAL REGULATORY CMC Biologics (R5)
Responsibilities:
- Serve as Regulatory CMC Project Lead; provide CMC regulatory leadership on cross-functional teams.
- Apply global CMC guidelines for IND/BLAs and post-approval changes.
- Deliver regulatory milestones for higher-complexity products; assess probability of success and define risk mitigation.
- Lead development/review of CMC Regulatory Strategy Documents.
- Lead global regulatory submissions for INDs, BLAs, and post-approval changes within defined timelines.
- Manage CMC documentation (IND/CTA, BLA/MAA, post-approval lifecycle), including background packages and responses to health authority questions.
- Collaborate on critical reviews to ensure compliance, scientific quality, accuracy, and completeness.
- Resolve complex issues and recommend actions to CMC regulatory leadership.
- Provide regulatory leadership for in-licensing/due diligence, divestment, and withdrawal; support new technology development.
- Maintain unwavering compliance focus; may manage/mentor junior team members.
Technical/Leadership Skills:
- Critically review scientific information and ensure conclusions are supported by data.
- Strong oral/written communication in multicultural settings.
- Sound understanding of manufacturing/analytical/quality and creative problem solving.
- Generate innovative solutions; flexible with changing priorities; lead effectively with stakeholders/health authorities.
Education:
- B.S. in biological science/engineering/related field (advanced degree preferred).
Required Experience/Skills:
- 10+ years relevant experience in biologics/vaccine Regulatory CMC or development/manufacturing/testing/licensure.
- Proficient English; travel periodically.
Preferred:
- Regulatory CMC experience in ADCs.
Benefits (if applicable): annual bonus/long-term incentive (if applicable); medical/dental/vision, retirement/401(k), paid holidays, vacation, compassionate and sick days.
Application:
- Apply via https://jobs.merck.com/us/en (deadline per posting). Requisition ID: R386607.
Responsibilities:
- Serve as Regulatory CMC Project Lead; provide CMC regulatory leadership on cross-functional teams.
- Apply global CMC guidelines for IND/BLAs and post-approval changes.
- Deliver regulatory milestones for higher-complexity products; assess probability of success and define risk mitigation.
- Lead development/review of CMC Regulatory Strategy Documents.
- Lead global regulatory submissions for INDs, BLAs, and post-approval changes within defined timelines.
- Manage CMC documentation (IND/CTA, BLA/MAA, post-approval lifecycle), including background packages and responses to health authority questions.
- Collaborate on critical reviews to ensure compliance, scientific quality, accuracy, and completeness.
- Resolve complex issues and recommend actions to CMC regulatory leadership.
- Provide regulatory leadership for in-licensing/due diligence, divestment, and withdrawal; support new technology development.
- Maintain unwavering compliance focus; may manage/mentor junior team members.
Technical/Leadership Skills:
- Critically review scientific information and ensure conclusions are supported by data.
- Strong oral/written communication in multicultural settings.
- Sound understanding of manufacturing/analytical/quality and creative problem solving.
- Generate innovative solutions; flexible with changing priorities; lead effectively with stakeholders/health authorities.
Education:
- B.S. in biological science/engineering/related field (advanced degree preferred).
Required Experience/Skills:
- 10+ years relevant experience in biologics/vaccine Regulatory CMC or development/manufacturing/testing/licensure.
- Proficient English; travel periodically.
Preferred:
- Regulatory CMC experience in ADCs.
Benefits (if applicable): annual bonus/long-term incentive (if applicable); medical/dental/vision, retirement/401(k), paid holidays, vacation, compassionate and sick days.
Application:
- Apply via https://jobs.merck.com/us/en (deadline per posting). Requisition ID: R386607.