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.
Post : Regulatory Affairs
Associate/Sr . Associate, Regulatory Affairs – Europe, Middle East & Africa (EMEA)
A. M. Pharma / MSc. with 5 years’+ of experience with PLCM for Europe in the pharmaceutical industry.
B. Assist in preparation, co-ordination and timely implementation of regulatory activities in support of PLCM submissions and other operational and cross functional activities for the selected products and markets across Europe. Conduct the peer review of pre - compiled e - CTD PLCM dossiers before final dispatch to EU RHQ.
C. Experience with Track - Wise, Lorenz Docubridge e - CTD system is a plus.
Associate/Sr. Associate Global Regulatory Affairs – APAC
A. M. Pharma / B.Pharma. with 5 years’+ of experience preferably in Prescription medicines with Australia and South East Asia region.
B. Within own portfolio compilation and submission of new dossiers for registration and variations of Apotex and in - licensed products in Australia, New Zealand and APAC (SEA). Maintenance of documentation/database records pertaining to products in own portfolio, in line with systems, processes and procedures.
C. Preparation of submission and approval notifications for applications submitted to regulatory agencies.
Associate - Global Regulatory Affairs PLCM
A. B.Pharma / M.Pharma / MSc. with 2 years’+ of experience with drug development and drug submissions for US/Canada markets.
B. Responsible for compilation and submission of dossiers for registration of Apotex products in identified markets.
WALK IN INTERVIEW
Date : 13th May, 2017 (Saturday)
Time : 09:00 AM – 4:00 PM
Venue : Apotex Research Private Limited {ARPL }, Gate No. 1, Plot 1&2, Bommasandra Industrial Area, Phase 4, Jigani Link Road, Bangalore – 560099
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