Assistant Manager -Regulatory Affairs

6 - 8 years

4.0 - 9.0 Lacs P.A.

Bengaluru

Posted:1 month ago| Platform: Naukri logo

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Skills Required

Regulatory AffairsDrug Regulatory AffairsAndaRA

Work Mode

Work from Office

Job Type

Full Time

Job Description

Role & responsibilities : Department : Regulatory Affairs , API Industry Designation : Assistant Manager Qualification : Msc in Chemistry Experience : 7 years Job Description : 1. Hands-on experience on New Drug Master File / Active Substance Master File to various Agencies (US, Europe, Health Canada, Japan, etc.,). 2. Life cycle maintenance to Drug Master File / Active Substance Master File to various Agencies (US, Europe, Health Canada, Japan, etc.,). 3. Responses to queries received from various Agencies. 4. Customer support for their ANDA approvals in various markets. 5. In change management system with respect to regulatory perspective. Please share resume to ramya_n@hikal.com

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