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Wednesday, July 7, 2010

Executive - Regulatory Affairs (API) IPMS Placements Pvt. Ltd. Baroda

Summary
Experience:
3 - 6 Years
Location:
Chennai, Mumbai, Vadodara/Baroda
Compensation:
Rupees 3,00,000 - 5,00,000
Education:
UG - B.Pharma - Pharmacy,B.Sc - Any Specialization,B.Tech/B.E. - Any SpecializationPG - M.Pharma - Pharmacy,M.Sc - Any Specialization,M.Tech - Any Specialization


Desired Candidate Profile
Idle candidates must be

M. Pharma with 3 to 6 yrs good experience in regulatory affairs.
Job Description
·         Preparing checklist for all new product filing, collecting, reviewing the data and screening for compilation.
·         Interaction with Regulatory agencies, plant and R & D.
·         Preparation of Letter of Authorization, Letter of Commitment, Technical Agreement and TSE/BSE and other declarations.
·         Preparation of MIS with regard to filings.
·         Storage & Archival of validation documents, electronic back up of filings and original COSs and certificates, Prepare and Coordinate for external audit at API manufacturing locations.
·         Compilation and in depth of reviewing of New Product DMFs for various regulated and less regulated markets against projected number of dossiers for the specified year.
·         Providing reference letters (LOA, LOC, and TA) to Commercial function and regulatory authorities whenever it's required.
·         Storage and archiving of all data and files pertaining to new product registrations, existing products and closed products.
·         Ensure Coordinating pre-submission audit at API locations and filing the reports.
Keywords: REGULATORY AFFAIRS, RA
Company Profile
Our client is

a reputed Pharmaceutical company and it has achieved amazing and consistent growth, quantitatively and qualitatively to emerge among the Top-15 companies in the Indian pharmaceutical industry in a short span of fourteen years of operations.
Contact Details
Company Name:
IPMS Placements Pvt. Ltd. Baroda.
Website:
Executive Name:
Rajendra Dholakiya
Address:
IPMS Placements Pvt Ltd
306, Opal Square, B/h. Express Hotel, R. C. Dutta
Road, Alkapuri
VADODARA,Gujarat,India 390007
Email Address:

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