Executive-Regulatory Affairs

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
Email	hrd@usv.co.in
Website	http://www.usvindia.com

Posted in: B.Pharmacy,M.Pharmacy,M.Sc,Mumbai,Regulatory Affairs