Regulatory CMC Manager

Jul 05, 2021

Job Description

500+ Ongoing clinical trials; 160+ Projects in clinical development; 80+ Major submissions planned 2020-2022. Novartis GDD (Global Drug Development) oversees the development of new medicines discovered by our researchers and partners. It drives breakthrough innovations to improve and extend the lives of millions.

Your key responsibilities:
Your responsibilities include, but are not limited to:
· Communicate and interpret China regulatory CMC requirements with global Reg CMC.
· Be responsible for local regulatory CMC dossiers preparation and compliant with local re-quirements.
a. Retrospectively review CMC queries from CDE for all projects and analyze the trend of CMC requirements.
b. Seek global support to provide relevant dossiers in new submissions.
· CMC support for local clinical trial activity, local registrations and product approvals, and regulatory compliance throughout the product lifecycle.
· Consolidate, contribute and coordinate Novartis comments on HA regulations and guidelines relevant to CMC.
· Establish and maintain sound working relationships with partners and customers and align objectives and priorities as appropriate to achieve optimal support.
· Coordinate CMC related trainings to RA team.

Minimum Requirements

Global Drug Development
Research & Development
Full Time

Regulatory CMC Manager

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