Executive - Regulatory Affairs (API) ~ PHARMANAUKRI.IN

Tuesday, June 8, 2010

Executive - Regulatory Affairs (API)

6:31 PM Leo Group India No comments

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.

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

Industry Type:

Pharma/ Biotech/Clinical Research

Role:

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.