Dr. Reddy's Laboratories Needs Regulatory Affairs Specialist
Post: Regulatory Affairs Specialist
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Job Description:
Compiling / Writing & submitting regulatory documents in an efficient and timely manner.
License applications-Test license, BE NOC, CT NOC, M&M application,Mfg license etc.
Preparation of ANDAs, NDAs
Review/preparation of amendments and supplements for deficiencies, if any
Review/ preparation of annual reports
Application of various licenses.
Participating in project meetings
Production of ANDAs
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Candidate Profile:
Work with Regulatory Agency(ies)/Consultants to derive/endorse key regulatory/clinical strategy(ies) – During R&D, pre- dossier submission, post-dossier submission
Review, compilation and submission of dossiers.
Collaborate and drive regulatory approvals with the local (India) and international regulatory body(ies).
Additional Information:
Experience: 2-6 Years
Education: B.Pharm, M.Pharm
Location: Hyderabad
Industry Type: Pharma/ Biotech/Clinical Research
Functional Area: DRA
Last Date: 30th Sept., 2011
You may share your profile at the following email address: tatipdo@drreddys.com
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