Job Description | 1.Preparation of technical packages. 2. Preparation of DMF's in CTD format for registration in regulated market Europe, USA, Japan, Canada, Australia etc. 3. Maintaining DMF status. 4. Filing of Annual Reports, DMF amendments 5. Compilation and review of plant and R&D documents 6. Response to letters from various health authorities 7. Checking/reviewing of documents received for DMF filing as per regulatory requirements 8. Guide site for regulatory filing documentation 9. Maintenance of lists/documents/records, communications, DMF submission records. 10. Co-ordinate with QA/production/ development for documents required for DMF filing. 11. Timely regulatory support to all API site / formulation sites. 12. To train API sites for Drug Master file documentation. |
Desired Profile | - Must have prior experience of API (DMF) regulatory filings. - Must have experience e-CTD submission. - Must have thorough knowledge of ICH / USFDA / EU - Regulatory experience in regulated markets,knowledge of various country requirements,ICH |
Experience | 3 - 4 Years |
Industry Type | Pharma/ Biotech/Clinical Research |
Role | Regulatory Affairs Mgr |
Functional Area | Healthcare, Medical, R&D |
Education | UG - B.Pharma - Pharmacy PG - M.Pharma - Pharmacy,M.Sc - Any Specialization |
Compensation: | compensation will be at par withh industry standards |
Location | Mumbai |
Keywords | regulatory affairs,Regulated markets,dossiers,documentation, API, DMF |
Contact | USV Limited |
hrd@usv.co.in | |
Website | http://www.usvindia.com |
Wednesday, January 5, 2011
Executive-Regulatory Affairs
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