Senior Scientist, Regulatory Affairs – CMC
Job in
Jersey City, Hudson County, New Jersey, 07390, USA
Listed on 2026-08-16
Listing for:
Jobtailor
Full Time
position Listed on 2026-08-16
Job specializations:
-
Pharmaceutical
Pharmaceutical Manufacturing, Medical Science Liaison, Regulatory Compliance Specialist
Job Description & How to Apply Below
- Provide input to global product and project regulatory strategies by performing assessments of CMC changes
- Execute regulatory strategies by leading the development, authoring and review of CMC submission components
- Liaise with global CMC, Manufacturing Division and external partners
- Assess and communicate potential regulatory risks and propose mitigation strategies
- Deliver all regulatory milestones for assigned products across the product lifecycle
- Bachelor’s in Science, Engineering, or a related field (advanced degree preferred but not required)
- up to 5 years Pharmaceutical industry experience or up to 2 years experience in managing CMC Regulatory submissions for small molecules/vaccines/biologics
- Adaptability
- Biopharmaceutical Industry
- Change Management
- Detail-Oriented
- Document Coordination
- Electronic Common Technical Document (eCTD)
- Interpersonal Relationships
- Pharmaceutical Manufacturing
- Regulatory CMC
- Writing Technical Documents
Demonstrates expertise in Regulatory CMC processes, including the development and submission of CMC components for small molecules, vaccines, and biologics. Proficient in managing regulatory milestones and assessing potential risks while ensuring compliance within the biopharmaceutical industry.
Highest-signal resume keywords- Regulatory CMC
- CMC Submission Management
- Electronic Common Technical Document (eCTD)
- Pharmaceutical Industry Experience
- Writing Technical Documents
- CMC Submission Management
- Regulatory CMC
- Writing Technical Documents
- Document Coordination
- Change Management
- Detail-Oriented
- Adaptability
- Interpersonal Relationships
- Biopharmaceutical Industry
- Pharmaceutical Manufacturing
- Electronic Common Technical Document (eCTD)
Position Requirements
10+ Years
work experience
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