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Associate Principal Scientist, Regulatory Chemistry, Manufacturing and Controls (CMC) - Biosimilars

Organon
Full-time
On-site
hybrid
Other
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Associate Principal Scientist, Regulatory Chemistry, Manufacturing and Controls (CMC) - Biosimilars

Company Name: Organon

Job Description

The Associate Principal Scientist will collaborate with internal teams and alliance partners to develop regulatory strategies for biosimilar projects, focusing on Regulatory CMC requirements. This includes overseeing assets in development through registration and post-launch, and supporting business development due diligence.

Responsibilities

  • Provide global strategic regulatory CMC overview
  • Serve as a regulatory CMC point of contact
  • Guide stakeholders in creating global regulatory CMC strategies
  • Lead the development and implementation of regulatory strategies