Opening for Sr. Associate/associate - Regulatory Affairs (api) @ Shasun Pharmaceuticals Ltd.
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Job Description

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    1) Preparation of DMF for API Regulatory markets

    2) Preparation of Amendments and Annual Reports

    3) Co-ordination with site personal for document requisition towards filing

    4) Hands on experience in API regulatory markets

    5) Basic Knowledge on regulatory guidelines and requirement on API

    6) Nature of deficiencies across the globe for proactive approach

    7) Review of Documents

    8) Review of change control documents for amendments filings

    9) Data collection and preparation of deficiency response

Salary: Not Disclosed by Recruiter

Industry: Pharma / Biotech / Clinical Research

Functional Area: Legal , Regulatory , Intellectual Property

Role Category:Drug Regulatory Affairs/Documentation

Role:Regulatory Affairs Manager
Keyskills
API
Regulatory Affairs
Desired Candidate Profile

Education-

UG: B.Sc - Chemistry

PG:M.Sc - Chemistry

Doctorate:Doctorate Not Required

Company Profile:

Shasun Pharmaceuticals Ltd.

www.shasun.com

Click here to apply

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