Senior Scientist, Regulatory CMC Biologics

MSD

Senior Scientist leading Regulatory CMC projects for biological drug development in cross-functional teams. Ensuring robust regulatory strategies and compliance throughout the product lifecycle.

Posted 4/26/2026full-timeNorth Wales • Massachusetts, New Jersey, Pennsylvania • 🇺🇸 United StatesSenior💰 $117,000 - $184,200 per yearWebsite

About the role

Key responsibilities & impact

Serve as a Regulatory CMC Project Lead and provide CMC Regulatory leadership within Regulatory and on cross-functional teams
Be accountable for the delivery of all regulatory milestones through product development and/or post-approval life cycle
Ensure development of robust CMC regulatory strategies for assigned projects
Manage execution of CMC documentation including IND/IMPD, original BLA/MAA, or Post approval/variations
Identify, communicate and escalate potential regulatory issues to Global Regulatory and Clinical Safety CMC management

Requirements

What you’ll need

B.S. in a science, engineering, or a related field (advanced degree preferred)
5 years of Regulatory CMC related experience
relevant experience including biological or vaccine drug substance/drug product development research, or manufacturing, testing and/or related field
Business Processes
CMC Documentation
CMC Strategy
Detail-Oriented
Document Coordination
Drug Product Development
Interpersonal Relationships
Pharmaceutical Products
Regulatory CMC
Regulatory Communications
Regulatory Compliance
Regulatory Interpretation
Regulatory Project Management
Regulatory Strategy Development
Writing Technical Documents

Benefits

Comp & perks

medical, dental, vision healthcare and other insurance benefits (for employee and family)
retirement benefits, including 401(k)
paid holidays
vacation
compassionate and sick days

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills & Tools

CMC DocumentationRegulatory CMCRegulatory ComplianceRegulatory Project ManagementRegulatory Strategy DevelopmentDrug Product DevelopmentWriting Technical DocumentsIND/IMPDBLA/MAABiological Drug Development

Soft Skills

Detail-OrientedInterpersonal RelationshipsCommunicationLeadershipAccountabilityProblem SolvingCollaborationEscalation ManagementStrategic ThinkingDocument Coordination

Certifications

B.S. in ScienceB.S. in EngineeringAdvanced Degree (Preferred)