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.
Regulatory Affairs EMEA ( Europe, Middle East, & Africa) Associate
M. Pharma/MSc. with 2 years+ of experience with PLCM for Europe in the pharmaceutical industry.
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
APAC (Asia Pacific) Associate & Sr. Associate
M. Pharma/B. Pharma. with 2 years+ of experience preferably in Prescription medicines with Australia and South East Asia region.
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.
Global Regulatory Affairs NPD Associate
M. Pharma/MSc. with 2 years+ of experience with drug development and drug submissions in the pharmaceutical industry.
Responsible for the preparation of quality regulatory submissions, especially for transdermal formulations, for various markets to ensure timely approval.
Responsible for the maintenance and timely completion of regulatory documents, especially for transdermal formulations, to support regulatory compliance in various markets.
Global Regulatory Affairs PLCM
M. Pharma/MSc. with 2 years+ of experience with drug development and drug submissions in the pharmaceutical industry.
Responsible for compilation and submission of dossiers for registration of Apotex products in identified markets.
Regulatory Intelligence & Training Associate
BSc./B. Pharma with 2 years+ of experience with regulatory affairs in the pharmaceutical industry.
Maintaining a central database and for performing statistical analysis/trending on deficiencies and/or concerns from regulatory agencies across various markets.
Walk IN Date : 7th March 2017
Walk IN Time: 10:00am to 5:00pm
Walk in Venue : Mumbai Office
Apotex Research Pvt Ltd [ARPL], 405, Town Centre 1, Andheri Kurla Road, Marol, Andheri (East), Mumbai-400059. Land Mark : Opp. Times Square Bldg.
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