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Submission Publisher

Tata Consultancy Services Limited

7 - 13 years

5 - 7 Lacs

Bengaluru / Bangalore Karnataka India

Posted:1 month ago| Platform: Foundit logo

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Skills Required

Analytical Organisational Skills Project Mgmt Life Science

Work Mode

On-site

Job Type

Full Time

Job Description

Roles & Responsibilities:- Utilize current electronic document management and publishing tools to prepare submission-ready Regulatory components and assemble, publish, and dispatch dossiers according to regulatory requirements for paper and electronic submissions with limited supervision Submission Dossiers that may be periodic (e.g.: safety reports) or minor amendments (e.g.: IND Amendment, DMF Amendment, CMC Update as appropriate to level, etc) or otherwise not major applications but in support of pending approvals or lifecycle commitments for marketed products (e.g.: meeting packages, responses as appropriate, Advertising and Promotion Submissions, routine labeling updates as appropriate, etc.) Global Regulatory knowledge of product registration procedures covering IND, NDAs, CTAs, BLA, IMPDs, MAAs for various countries including regulated markets like US, EU, Canada and Australia-NZ Support regulatory submissions publishing for EDMF, COS/CEP for Drug substance related filing and regulatory submissions publishing in MRP, DCP, CP and National filing for the EU Reviews and maintains regulatory database comprising existing and new regulations pertaining to submission requirements for the region QC submission dossiers or parts of submission dossier output of low-tomoderate and moderate-to-high complexities as assigned.

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