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Saturday, February 26, 2011

Regulatory Executive 2 Opening(s) Gepach International


Summary

Experience:
2 - 7 Years
Location:
Mumbai Suburbs
Compensation:
Rupees 90,000 - 2,50,000
Commensurate to Profile
Education:
UG - B.Pharma - Pharmacy,B.Sc - Any Specialization, Bio-Chemistry, Chemistry, Microbiology,Diploma - Any Specialization,MBBS - MedicinePG - M.Pharma - Pharmacy,M.Sc - Any Specialization, Bio-Chemistry, Chemistry, Food Technology, Microbiology,M.S/M.D - Any Specialization,PG Diploma - Any Specialization
Industry Type:
Pharma/ Biotech/Clinical Research
Role:
Regulatory Affairs Mgr
Functional Area:
Healthcare, Medical, R&D
Posted Date:
25 Feb

Desired Candidate Profile

B.Pham or M.Pham with relevant experience in Regulatory Affairs

Job Description

  1. Shall be responsible for Regulatory Affairs function.
  2. Organizing the required documents for ACTD submission.
  3. Respond to queries raised by regulatory authorities.

    Implementation of SPL and eCTD
  4. Preparation of drug master files (DMF), site master files and dossiers for CIS, European, Asian & African markets.
  5. Coordination with various departments like R&D, AD, QC, QA, Production and Validation for maintaining database for registration Submission.
  6. Preparation and submission ANDA, ANDS in CTD format.
  7. Knowledge of regulatory guidelines for preparation of artworks.
  8. Review, Compilation and Submission of dossiers / documents in a scheduled time frame.

     
Keywords: Regulatory Affairs Manager, Regulatory Executive, Formulation Specialist.

Company Profile

We are Exporters of Pharmaceutical & Nutraceutical products to Europe, Africas, Russia, CIS and South east Asia.
Contact Details
Company Name:
Gepach International
Executive Name:
Mr K B Tarapore
Address:
Gepach International
318,22-24, Kakad Corner Andheri Kurla Road
Andheri (e)
MUMBAI,Maharashtra,India 400059
Email Address:
Telephone:
91-22-67022459

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