Formulation Regulatory Affairs Executive/ Assistant Manager Hetero

3.0 - 8.0 years

3 - 8 Lacs

Hyderabad

Work from Office

Role & responsibilities Keen Knowledge on Regulatory guidelines for finished product registration. Dossier compilation as per guidelines. Compilation and review the product dossiers for submission in CTD, ACTD . Gap analysis of the dossier and addressing the gaps before submission to MOH. Handling the customer and MOH queries . Life cycle management of the product. Development report, scale up report , specification, COA, stability protocol and Process validation protocol. Documents review (Specification, STP, Analytical method validations, Development report and validation reports, BMR, BPR, PVP/R and stability). Post approval experience to file the applicable variations timely. Knowledge o...

Posted 5 months ago

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Regulatory Affairs - Manager / Deputy Manager AET Laboratories

10 - 15 years

13 - 15 Lacs

Hyderabad

Work from Office

Role & responsibilities Extensive Knowledge in Pre-Submission activity and handling new product submissions. Handling of post approval activities (US/EU and ROW) Experience in handling life cycle management Activities. Line Extension and New Submissions. Well versed in applicable regulatory and country specific guidlines.

Posted 5 months ago

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