Team Lead

Biological E. Limited

0 years

0 Lacs

Shamirpet Telangana India

Posted:1 week ago| Platform:

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Skills Required

management portfolios export marketing authorization

Work Mode

On-site

Job Type

Full Time

Job Description

Experienced in handling, management and expansion of product portfolios, markets/ territories.
Experienced in the preparation, review and submission of applications/ response to RCGM vide IBSC.Expertise in preparation, compilation and submission of Indian NRA applications (Eg: Form CT 10, 16, CT18, 40, 10, Export NoC, etc., but not limited)Well versed with Indian NRA submission portals, IBKP, SUGAM, NSWS, ODLS/ ONDLS, etc.Author, review and compilation of Regulatory Packages like Briefing documents, Scientific package, Pre-IND packages, Clinical Trial, Expedited request, Pre-qualifications, etc.Author, review, compile and submission of Marketing Authorization Applications (CTD/ ACTD/ eCTD) in India, Emerging Markets, Regulated Markets and Vaccine Prequalification Dossier to WHO.Application for Post Approval Change(s), Variations and Comparability packages

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Biological E. Limited

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Team Lead