Summary
Experience:
2 - 7 Years
Location:
Mumbai Suburbs
Compensation:
Rupees 90,000 - 2,50,000
Commensurate to Profile
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
- Shall be responsible for Regulatory Affairs function.
- Organizing the required documents for ACTD submission.
- Respond to queries raised by regulatory authorities.
Implementation of SPL and eCTD - Preparation of drug master files (DMF), site master files and dossiers for CIS, European, Asian & African markets.
- Coordination with various departments like R&D, AD, QC, QA, Production and Validation for maintaining database for registration Submission.
- Preparation and submission ANDA, ANDS in CTD format.
- Knowledge of regulatory guidelines for preparation of artworks.
- 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
Website:
Executive Name:
Mr K B Tarapore
Address:
Gepach International
318,22-24, Kakad Corner Andheri Kurla Road
Andheri (e)
MUMBAI,Maharashtra,India 400059
318,22-24, Kakad Corner Andheri Kurla Road
Andheri (e)
MUMBAI,Maharashtra,India 400059
Email Address:
Telephone:
91-22-67022459
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