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Nectar Lifesciences Limited logo
Regulatory Affairs Manager (APIs) Nectar Lifesciences Limited

3.0 - 7.0 years

0 Lacs

punjab

On-site

You will be responsible for managing the DMFs & CEPs application process, CADIFA Application, and Annual Report for USDMFs. Your role will involve utilizing your knowledge of ICH, PIC/s, and EMEA guidance to prepare and submit KDMFs, CDMFs, and JDMFs. Additionally, you will be required to handle submissions on the CESP Portal and Solicita Portal, ensuring compliance with ESG (USFDA) standards. Your tasks will also include publishing and e-Validation. - Proficiency in managing DMFs & CEPs application process - Familiarity with CADIFA Application and Annual Report for USDMFs - Knowledge of ICH, PIC/s, and EMEA guidance - Experience in compiling and submitting KDMFs, CDMFs, and JDMFs - Ability ...

Posted 5 days ago

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