NOVARTIS Hirirng RA CMC
Associate Manager – I Science Degree inChemistry, Pharmacy, Biochemistry,
Biotechnology, Biology Apply Now
Job Description
-Author high -quality global CMC documentation for Health Authority
submission throughout the product lifecycle, applying agreed CMC global
regulatory strategies, current regulatory trends and guidelines.
Ensure technical congruency and regulatory compliance, meeting
agreed upon timelines and e -publishing requirements.
-Identify the required documentation and any content, quality and/or
timeliness issues for global submissions and negotiate the delivery of approved
technical source documents in accordance with project timelines.
-As needed, coordinate
/collect/store source documentation needed for direct submission to Health
Authorities.
-Actively participate as a member of the global RA CMC team by
contributing to the regulatory strategy, identifying the critical issues and
lessons learned.
-Perform activities in support of the overall department such as
data entry into the Regulatory Information Management System, other CMC
database entry, or maintenance and operational activities as needed.
Minimum requirements
Education: - Minimum: Science Degree (e.g. Chemistry, Pharmacy,
Biochemistry, Biotechnology, Biology) or equivalent - Desirable: Advanced
Science Degree
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