Regulatory Affairs Manager (APIs)

Nectar Lifesciences Limited

3 - 7 years

0 Lacs

punjab

Posted:5 days ago| Platform: Shine logo

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Skills Required

pics managing dmfs ceps application process cadifa application annual report for usdmfs knowledge of ich emea guidance compiling submitting kdmfs cdmfs jdmfs handling submissions on cesp portal solicita portal understanding of esg usfda standards publishing evalidation processes

Work Mode

On-site

Job Type

Full Time

Job Description

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 to handle submissions on CESP Portal and Solicita Portal - Understanding of ESG (USFDA) standards - Competence in publishing and e-Validation processes,

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