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.
esignation Associate-Regulatory Compliance Job Description 1.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 QueriesDesired Profile 2-6 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.Experience 2 - 6 Years Industry Type Pharma/ Biotech/Clinical Research Role Regulatory Affairs Mgr Functional Area Healthcare, Medical, R&D Education UG - B.A,B.Pharma,B.Sc - Chemistry
PG - Any PG Course,Post Graduation Not Required,M.Pharma,M.Sc - ChemistryLocation Bengaluru/Bangalore, Mumbai Keywords Regulatory ,Regulated Market,ROW Contact Mr.Saikat Sen
Apotex Research Pvt Ltd Email careers@apotex.co.in Website http://www.apotex.com
Friday, July 16, 2010
Associate-Regulatory Compliance
nmr
Jobs By Category
Manufacturing/Production Quality Control Quality Assurance
Regulatory Affairs Research & Development Clinical Research
Warehouse/Stores HR Jobs Contract Manufacturing Supply Chain / PPIC
Purchase jobs Marketing PharmacoVigilance
Jobs By Location
Baddi Bhopal Chandigarh Solapur Hosur Gangtok Gurgaon
Mohali Baroda Ankleshwar Ahmedabad Delhi Mumbai Chennai
Hyderabad Bangalore Goa Gujarat Pune
Jobs By Qualification
Ph.D M.Sc MBBS M.Pharmacy MBA M.Com M.Tech B.Tech
B.Pharmacy B.Sc D.Pharmacy B.Com Intermediate Any Graduate
ITI SSC
Jobs for Freshers
Freshers
Manufacturing/Production Quality Control Quality Assurance
Regulatory Affairs Research & Development Clinical Research
Warehouse/Stores HR Jobs Contract Manufacturing Supply Chain / PPIC
Purchase jobs Marketing PharmacoVigilance
Jobs By Location
Baddi Bhopal Chandigarh Solapur Hosur Gangtok Gurgaon
Mohali Baroda Ankleshwar Ahmedabad Delhi Mumbai Chennai
Hyderabad Bangalore Goa Gujarat Pune
Jobs By Qualification
Ph.D M.Sc MBBS M.Pharmacy MBA M.Com M.Tech B.Tech
B.Pharmacy B.Sc D.Pharmacy B.Com Intermediate Any Graduate
ITI SSC
Jobs for Freshers
Freshers

0 comments:
Post a Comment