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Friday, July 16, 2010

Associate-Regulatory Compliance

Apotex`Research Pvt. Ltd. is a wholly owned subsidiary of Apotex Inc. Canada which is a number one generic pharma co. in Canada. The position is for Bangalore location which has an R&D Centre, Manufacturing and a Bioequivalence Centre.

esignationAssociate-Regulatory Compliance
Job Description1.Response to various quires, amendment of various deficiencies, reviewing of documents from regulatory point of view.

2.Expertise in preparing, reviewing labeling, pack insert, product monograph and master documents like BPR, BMR, CCF, specifications and other relevant documents by giving comments or amendments on regulatory point of view.

3.To co-ordinate, assist, collect and verify data while achieving allotted submission in e CTD format to various regulatory agencies meant for US, CANADA, EUROPE

4.Preparation and organizing ANDA and Dossiers submission.

Preparation of structure product Labeling(SPL) for ANDA---(eCTD Submission)

5.Preparation of responses to ANDA CMC as well as Labeling deficiencies.

6.Review of specifications as per monographs. (USP/Ph.Eur).

7.Review of process qualification and product development records.

8.Review of stability data.

9.Review of innovator comparative dissolution data.

10.Review of all documents related to Formulation Development.

11.Art work approval, side by side comparison both PIL and Labels.

12.Document follow up for FDA/Regulatory Queries
Desired Profile2-6 yrs of work experience in regulated Affairs of US/EU Canadafor formulation applications .

M.Pharm/B.Pharm/B.Sc [Chemistry]/M.Sc [Chemistry ] with experience can apply.
Experience2 - 6 Years
Industry TypePharma/ Biotech/Clinical Research
RoleRegulatory Affairs Mgr
Functional AreaHealthcare, Medical, R&D
EducationUG - B.A,B.Pharma,B.Sc - Chemistry
PG - Any PG Course,Post Graduation Not Required,M.Pharma,M.Sc - Chemistry
LocationBengaluru/Bangalore, Mumbai
KeywordsRegulatory ,Regulated Market,ROW
ContactMr.Saikat Sen
Apotex Research Pvt Ltd


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