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CMC Regulatory Affairs Manager

2 months ago

New York, New York, United States Katalyst HealthCares & Life Sciences Full time

Position Overview:
We are seeking a qualified individual to take on the role of CMC Documentation Manager within our organization. This position is crucial for the development of Chemistry, Manufacturing, and Control (Module ) documentation for our marketed products.

  • Accountable for the preparation of CMC registration documentation under the supervision of CMC product leaders.
  • Responsible for the creation and maintenance of regulatory CMC documents within our document management system.
  • Develop comprehensive technical CMC registration documents to ensure adherence to regulations across multiple jurisdictions.
  • Oversee the assembly of high-quality Common Technical Document (CTD) Module and Quality Overall Summary (QOS) documents for regulatory submissions.
  • Collaborate with project teams to assess change requests and ensure compliance with technical specifications.
  • Revise technical registration dossiers for pharmaceutical products while remaining informed about industry standards.
  • Work cross-functionally to resolve technical regulatory inquiries and draft appropriate responses.

Qualifications:

  • A Bachelor's or Master's degree with relevant professional experience.
  • Strong skills in developing and managing business processes.
  • Experience with IT-based scientific systems and global CMC/Module development.
  • Knowledge of the US regulatory landscape and post-approval CMC modifications.
  • Proficient in English; knowledge of German and/or French is advantageous.