Principal Scientist (Director) - Regulatory Affairs-CMC
Merck
July 02, 2026
Remote friendly (North Wales, PA)
United States
Corporate Functions
Principal Scientist / Director, GLOBAL REGULATORY CMC Biologics
Responsibilities:
- Develop and implement global Chemistry, Manufacturing, and Controls (CMC) regulatory strategies for biologics franchises.
- Lead preparation and submission of CMC sections for commercial/new biologics products.
- Serve as Regulatory CMC Project Lead; provide CMC regulatory leadership across Regulatory and cross-functional teams.
- Apply global CMC guidelines for IND/BLAs and post-approval changes; deliver regulatory milestones for higher-complexity products, including risk mitigation.
- Lead development/review of the CMC Regulatory Strategy Document.
- Lead global IND/BLA/MAA (or post-approval change) submission development and execution to defined timelines.
- Manage CMC documentation and agency background packages; respond to health authority questions.
- Collaborate on critical review for compliance, accuracy, scientific excellence, and completeness.
- Resolve complex issues; provide recommendations to Regulatory CMC leadership.
- Provide regulatory leadership for in-license/due diligence, divestment, and withdrawal.
- Support new technology development; maintain unwavering compliance focus.
- Mentor/manage junior team members as needed.
Technical/Leadership Skills:
- Critically review scientific information and ensure conclusions are data-supported.
- Strong oral/written communication in multicultural settings; ability to communicate complex issues succinctly.
- Sound understanding of manufacturing, analytical, QA; creative problem-solving.
- Generate innovative solutions; stakeholder engagement; flexibility with changing priorities; leadership with cross-functional partners and health authorities.
Education:
- BS in biological science/engineering/related field (advanced degree preferred).
Required:
- 10+ years relevant experience in biologics/vaccine Regulatory CMC or development/manufacturing/testing/licensure.
- Proficient English; additional languages a plus; periodic travel may be required.
Preferred:
- Regulatory CMC experience in ADCs.
Application:
- Apply at https://jobs.merck.com/us/en (Workday Jobs Hub for current employees). Apply by the posting’s stated deadline.
Responsibilities:
- Develop and implement global Chemistry, Manufacturing, and Controls (CMC) regulatory strategies for biologics franchises.
- Lead preparation and submission of CMC sections for commercial/new biologics products.
- Serve as Regulatory CMC Project Lead; provide CMC regulatory leadership across Regulatory and cross-functional teams.
- Apply global CMC guidelines for IND/BLAs and post-approval changes; deliver regulatory milestones for higher-complexity products, including risk mitigation.
- Lead development/review of the CMC Regulatory Strategy Document.
- Lead global IND/BLA/MAA (or post-approval change) submission development and execution to defined timelines.
- Manage CMC documentation and agency background packages; respond to health authority questions.
- Collaborate on critical review for compliance, accuracy, scientific excellence, and completeness.
- Resolve complex issues; provide recommendations to Regulatory CMC leadership.
- Provide regulatory leadership for in-license/due diligence, divestment, and withdrawal.
- Support new technology development; maintain unwavering compliance focus.
- Mentor/manage junior team members as needed.
Technical/Leadership Skills:
- Critically review scientific information and ensure conclusions are data-supported.
- Strong oral/written communication in multicultural settings; ability to communicate complex issues succinctly.
- Sound understanding of manufacturing, analytical, QA; creative problem-solving.
- Generate innovative solutions; stakeholder engagement; flexibility with changing priorities; leadership with cross-functional partners and health authorities.
Education:
- BS in biological science/engineering/related field (advanced degree preferred).
Required:
- 10+ years relevant experience in biologics/vaccine Regulatory CMC or development/manufacturing/testing/licensure.
- Proficient English; additional languages a plus; periodic travel may be required.
Preferred:
- Regulatory CMC experience in ADCs.
Application:
- Apply at https://jobs.merck.com/us/en (Workday Jobs Hub for current employees). Apply by the posting’s stated deadline.