CMC Regulatory Affairs Specialist

5 days ago

Matthews, North Carolina, United States Katalyst Healthcares and Life Sciences Full time
Job Summary

We are seeking a highly skilled CMC Regulatory Affairs Specialist to join our team at Katalyst Healthcares and Life Sciences. As a key member of our regulatory team, you will be responsible for ensuring compliance with FDA, EMA, and global regulatory requirements for our clients.

Key Responsibilities
  • Author and review high-quality, compliant CMC regulatory documents, including Core Dossiers, INDs, CTAs, MAAs, BLAs, and Variations.
  • Support clients in responding to health authority questions within defined timelines.
  • Perform assessments of CMC changes, identifying global regulatory requirements, and evaluating supporting documentation to assess acceptability and identify potential risks.
  • Collaborate with clients and partners to collect necessary sources, communicate issues or risks proactively, and ensure compliance with regulatory requirements.
  • Compile documentation for regulatory submission packages, including license renewals, updates, and market registration for review and submission to regulatory agencies.
  • Perform technical reviews of certificate of analysis, analytical test methods, specification, product development reports, Master Batch Records, validation protocol/report, and stability protocol/report/data.
  • Work within multiple regulatory systems and tools during the end-to-end submission process.
  • Maintain knowledge of current FDA, EU, and global regulations and guidance applicable to marketed products.
  • Support and prepare other CMC ad-hoc requests as per client requests.
Requirements
  • Bachelor's degree in a health or life science discipline is required; Advanced degree is preferred.
  • 5+ years of experience in the pharmaceutical industry in research, manufacturing, analytical, or quality.
  • 2+ years of experience in Regulatory-CMC.
  • Ability to read, analyze, and interpret technical documents and health authority regulations.
  • Demonstrated experience authoring CMC sections in Module 1, 2, and 3 sections of regulatory filings.
  • Familiar with Common Technical Document (CTD) formatting.
  • Working knowledge of the US and European regulations and ICH guidance is preferred.
  • Demonstrated experience using regulatory systems and tools, such as TrackWise and Veeva Vault.
  • Strong computer proficiency in the use of the MS Office Suite (Word, Outlook, PowerPoint, and Excel).

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