We are looking for candidate with experience in RAD Department at Executive level for Apitoria Pharma Private Ltd., (100% subsidiary of Aurobindo Pharma) located at Hyderabad.
Requirement Details:
Job description:
*Compilation of drug substance modules for global market – New submissions
*Life cycle management – Amendments/Responses compilation
*Evaluation of the change controls.
*Drafting and sending the change notification to customers till its implementation.
*Maintaining various dashboards related to regulatory submissions and life cycle management
Skills required:
*Good understating life cycle management in API regulatory affairs
*Clarity on regulatory guidance documents on post approval changes
*Experience in drafting/reviewing the Module 3 of API
Interested candidates can apply by scanning the QR code given in the poster.
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