Associate Principal Scientist, Regulatory CMC Product Lead
Employment type
Full-time
Work setting
On-site
Location
Florham Park, NJ
Schedule
Day shift
Posted
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Job overview
The Associate Principal Scientist, Regulatory CMC Product Lead role is listed in Florham Park, NJ, with remote work arrangements described in the posting. Compensation is not specified. The role supports Organon’s Regulatory Chemistry, Manufacturing and Controls organization, within a company focused on health solutions including women’s health and biosimilars. The role owns regulatory CMC milestones for assigned products, translating global requirements and scientific documentation into strategies and submissions that support product approval and supply continuity. It coordinates with manufacturing, supply colleagues, and external partners to manage lifecycle changes and regulatory risks.
What you'll do
- Serve as CMC Product Lead for assigned products and deliver regulatory milestones across the product lifecycle
- develop and execute global product and project regulatory strategies
- assess CMC changes, requirements, supporting documentation, and risks
- lead preparation, authoring, review, and submission of CMC components for supplements, annual reports, renewals, and health authority responses
- support due diligence, divestment, and withdrawal activities as needed
- collaborate with Manufacturing & Supply and external partners on compliant change management
- communicate and escalate regulatory issues.
What we're looking for
- Skills & competencies
- associate principal scientistregulatory cmccmc product leadsmall molecule productsbiological productslifecycle managementregulatory submissionsflorham park njorganonremote workpost-approval changes
- Work arrangement
- Weekend coverage required
Benefits & perks
- Retirement savings plan
- paid vacation and holidays
- paid caregiver, parental, and medical leave
- medical, prescription drug, dental, and vision coverage.
Why this role
May manage one to two individual contributors and/or outsourcing partners; remote work is listed among flexible work arrangements.
About the employer
Organon & Co. is hiring for this role. Industry: Pharmaceutical Preparation Manufacturing. Sector: 32.
Additional details
- Industry sector
- 32
- Industry
- Pharmaceutical Preparation Manufacturing
- Occupation code
- 19-2031.00
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Listing ID: 78e212f8-a12d-4b7e-ad73-024dbe004b2d