Associate Principal Scientist, Regulatory Affairs – CMC

MSD

Associate Principal Scientist managing CMC regulatory strategies for pharmaceutical products in a hybrid role. Collaborating with global teams to ensure compliance and successful regulatory submissions.

Posted 4/30/2026full-timeNew Jersey, Pennsylvania • 🇺🇸 United StatesJuniorMid-Level💰 $142,400 - $224,100 per yearWebsite

About the role

Key responsibilities & impact

Serve as a CMC Product Lead for assigned products and be accountable for the delivery of all regulatory milestones through product development
Lead development and execution of global product and project regulatory strategy(ies) by ensuring robust assessment of global regulatory CMC requirements and critical evaluation of supporting documentation
Lead the development, communication, lifecycle management and review of the CMC Regulatory Strategy Document for assigned projects
Provide regulatory leadership as needed in product in-license/due diligence review and product transition to the Post-Approval Pharm CMC team
Manage execution of CMC documentation including IND/CTA, original NDA/MAA, agency background packages and responses to health authority questions
Identify, communicate and escalate potential regulatory issues to GRACS CMC management
Conduct all activities with an unwavering focus on compliance

Requirements

What you’ll need

Bachelor's degree in a biological science, engineering, or a related field (advanced degree preferred)
At least five (5) years of relevant experience, including biological/pharmaceutical research; manufacturing, testing, or regulatory CMC; or related fields
Proficient in English; additional language skills are a plus.
Experience in Regulatory CMC or in preparation of regulatory filings with technical leadership skills
Demonstrated understanding of related pharmaceutical operations (e.g., manufacturing, process development, analytical, quality assurance)
Ability to develop innovative and imaginative approaches to problem solving
Ability to flexibly respond to changing priorities or unexpected events
Superb collaboration skills
Rapid, disciplined decision making and critical thinking capabilities
Excellent interpersonal, verbal and written communication, presentation, and listening skills

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

regulatory CMCIND/CTA documentationNDA/MAA documentationregulatory filingsbiological/pharmaceutical researchmanufacturingprocess developmentanalyticalquality assurance

Soft Skills

problem solvingcollaborationdecision makingcritical thinkingcommunicationpresentationlisteningflexibilityleadership

Certifications

Bachelor's degreeadvanced degree (preferred)