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Dr Reddys
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Regulatory Affairs Specialist

Regulatory Affairs Specialist

Dr Reddys

3 - 6 years

10 - 20 Lacs

Hyderabad

Posted:1 month ago| Platform:

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Skills Required

ectd pharmaceutical anda regulatory drug safety dossier networking ent artwork pharmacovigilance labels regulatory requirements ra ich ctd canada clinical research writing regulatory affairs drug regulatory affairs regulatory guidelines communication skills

Work Mode

Work from Office

Job Type

Full Time

Job Description

Preparation & review of US ANDAs/ 505(b)(2)/EU/ Canada dossiers for Parenteral products as per regulatory requirements. Preparation & review of deficiency responses, regulatory strategy note, controlled correspondences, Briefing books, labeling, artworks and ScA meeting packages. Coordinate with internal stake holders (R&D, AR&D, SCM, FTO, CTO etc) and external counterparts (CMO & CRO) to review regulatory documents and proposals and provide strategic inputs. Identify all open issues at product development, ANDA filing and deficiency responses in consultation with team lead/RA vertical head. Provide support to commercial launch team w.r.t review progress and evaluate changes proposed for commercial batches (batch records, specifications, analytical method Stability protocols, PVPs etc).In coordination with eCTD / labeling team, ensure that the eCTD publication and Dossiers are filed according to regulatory guidelines. Qualification M. Pharm, M.Sc PhD Additional Information Good communication skill (Written and Oral), Self-starter with a go-getter attitude and team player, Quick learner and able to prioritize information, Good interpersonal skills, High level of proficiency in networking internally and externally.

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Regulatory Affairs Specialist