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Tuesday, June 8, 2010

Executive - Regulatory Affairs (API)

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.


3 - 6 Years
Chennai, Mumbai, Vadodara/Baroda
Rupees 3,00,000 - 5,00,000
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
Industry Type:
Pharma/ Biotech/Clinical Research
Regulatory Affairs Mgr
Functional Area:
Healthcare, Medical, R&D

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.
Contact Details
Company Name:
Innovative Placement & Management Services, Baroda
Executive Name:
Rajendra Dholakiya
IPMS Placements Pvt Ltd
306, Opal Square, B/h. Express Hotel, R. C. Dutta
Road, Alkapuri
VADODARA,Gujarat,India 390007


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