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Executive-Regulatory Affairs

By: Pharma Career | Views: 888 | Date: 04-Jan-2011

- 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,ICH3 - 4 Years

Job Description1.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
Experience3 - 4 Years
Industry TypePharma/ Biotech/Clinical Research
RoleRegulatory Affairs Mgr
Functional AreaHealthcare, Medical, R&D
EducationUG - B.Pharma - Pharmacy
PG - M.Pharma - Pharmacy,M.Sc - Any Specialization
Compensation:compensation will be at par withh industry standards
LocationMumbai
Keywordsregulatory affairs,Regulated markets,dossiers,documentation, API, DMF
ContactUSV Limited 
Emailhrd@usv.co.in
Websitehttp://www.usvindia.com
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