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.
Keywords: REGULATORY AFFAIRS, RA
Contact Details
Company Name:
Innovative Placement & Management Services, Baroda
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
306, Opal Square, B/h. Express Hotel, R. C. Dutta
Road, Alkapuri
VADODARA,Gujarat,India 390007
Email Address:
0 comments:
Post a Comment