Executive - Regulatory Affairs (API) Innovative Placement & Management Services, Baroda

Preparing checklist for all new product filing, collecting, reviewing the data and screening for compilation.

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

Posted Date:

07 May

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:

Innovative Placement & Management Services, Baroda

Website:

http://www.innovativeplacement.com

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:

resume@innovativeplacement.com

Posted in: Regulatory Affairs