Senior Scientist, Regulatory Affairs – CMC

MSD

Sr. Scientist responsible for implementing CMC regulatory strategies for pharmaceutical products.

Posted 7/29/2026full-timeNorth Wales • New Jersey, Pennsylvania • 🇺🇸 United StatesSenior💰 $117,000 - $184,200 per yearWebsite

Core Competencies

Role fit

Core Competencies

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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 CMCCMC Submission ManagementElectronic Common Technical Document (eCTD)Pharmaceutical Industry ExperienceWriting Technical Documents

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

CMC Submission ManagementRegulatory CMCWriting Technical DocumentsDocument CoordinationChange Management

Soft Skills

Detail-OrientedAdaptabilityInterpersonal Relationships

Tools & Technologies

Electronic Common Technical Document (eCTD)

Industry Keywords

Biopharmaceutical IndustryPharmaceutical Manufacturing

About the role

Key responsibilities & impact

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

Requirements

What you’ll need

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

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