Dear All now get GMP News, FDA, WHO, EU, TGA, CDSCO guidelines...and GMP Violations news/warning letters.. GMPVIOLATIONS

Wednesday, January 5, 2011

Executive-Regulatory Affairs

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
Keywordsregulatory affairs,Regulated markets,dossiers,documentation, API, DMF
ContactUSV Limited


Post a Comment

Related Posts Plugin for WordPress, Blogger...
Enter your email address: Updated Regularly || Click here for Get Free SMS Alerts |


 Jobs By Category

Manufacturing/Production     Quality Control    Quality Assurance

Regulatory Affairs     Research & Development     Clinical Research

Warehouse/Stores HR Jobs     Contract Manufacturing     Supply Chain / PPIC

Purchase jobs      Marketing PharmacoVigilance 

 Jobs By Location

Baddi     Bhopal     Chandigarh     Solapur     Hosur     Gangtok     Gurgaon    

Mohali     Baroda Ankleshwar     Ahmedabad     Delhi      Mumbai      Chennai    

Hyderabad     Bangalore     Goa     Gujarat      Pune    

 Jobs By Qualification  

Ph.D     M.Sc     MBBS     M.Pharmacy     MBA     M.Com      M.Tech     B.Tech     

B.Pharmacy      B.Sc     D.Pharmacy     B.Com     Intermediate   Any Graduate      

ITI     SSC    

Jobs for Freshers


Enter Key word then search


Twitter Delicious Facebook Digg Stumbleupon Favorites