Emcure Pharmaceuticals is one of the leading players in the Indian Pharmaceutical industry with global operations. What Emcure offers an individual is a great opportunity to work with one of the most dynamic organizations in the pharmaceutical industry, a steep learning curve, high responsibility levels and the chance to grow with the organization. The state of the art R & D centre, high tech manufacturing facility, suave marketing strategy and a committed and competent workforce has enabled Emcure to carve it’s niche in the Pharmaceutical industry.
Responsible for :
a. Bioequivalence studies of products to be developed for regulated markets – US / EU.
b. Interaction with CROs : Identification of suitable CRO for conducting the BE studies, Audits of CRO facilities, Support BE study protocol preparation, Monitor the BE studies, Review the BE studies reports, bioanalytical method validation and reports, statistical reports
c. Interaction with Formulation development : Review the dissolution studies, provide inputs w.r.t pharmacokinetics of the molecule, Analyze the BE reports and provide guide further development of product
d. Interaction with Regulatory dept : Provide BE studies protocol for NOC from local regulatory agencies – DCGI, ethics committee. Submit BE studies report in CTD format for dossier compilation and submission to regulatory agencies. Provide inputs for any query
Salary : Mediclaim benifits, canteen, good culture
Education : Ph.D Life Science
Contact Details :
Executive Name:Mr. Monish Kulkarni
Email : resume@emcure.co.in
Contact Company:Emcure Pharmaceuticals Ltd
Address: Survey No.255/2,
Phase 1 Rajiv Gandhi IT Park MIDC,
Hinjewadi PUNE,Maharashtra,India 411057
Deadline : 20.01.12
Responsible for :
a. Bioequivalence studies of products to be developed for regulated markets – US / EU.
b. Interaction with CROs : Identification of suitable CRO for conducting the BE studies, Audits of CRO facilities, Support BE study protocol preparation, Monitor the BE studies, Review the BE studies reports, bioanalytical method validation and reports, statistical reports
c. Interaction with Formulation development : Review the dissolution studies, provide inputs w.r.t pharmacokinetics of the molecule, Analyze the BE reports and provide guide further development of product
d. Interaction with Regulatory dept : Provide BE studies protocol for NOC from local regulatory agencies – DCGI, ethics committee. Submit BE studies report in CTD format for dossier compilation and submission to regulatory agencies. Provide inputs for any query
Salary : Mediclaim benifits, canteen, good culture
Education : Ph.D Life Science
Contact Details :
Executive Name:Mr. Monish Kulkarni
Email : resume@emcure.co.in
Contact Company:Emcure Pharmaceuticals Ltd
Address: Survey No.255/2,
Phase 1 Rajiv Gandhi IT Park MIDC,
Hinjewadi PUNE,Maharashtra,India 411057
Deadline : 20.01.12
