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Formulation Regulatory Affairs Executive/ Assistant Manager

Formulation Regulatory Affairs Executive/ Assistant Manager

Hetero

3 - 8 years

3 - 8 Lacs

Hyderabad

Posted:2 months ago| Platform:

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Skills Required

Dossier Preparation Regulatory Affairs cmc Variation Emerging Markets OSD Solid Orals Compilation Submission Europe Approvals Dossier Compilation Ectd RA ICH CTD Row Market Anda Uk Formulation Dossier Injectables Row

Work Mode

Work from Office

Job Type

Full Time

Job Description

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 on EAEU, ICH and EMEA guidelines. Re-registration (Renewal) procedures. Administrative documents requirements (COPP, Mfg. License and Import License) . Registration information management system updates on regular basis.

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Formulation Regulatory Affairs Executive/ Assistant Manager