1 Opening(s)
2.0 Year(s) To 10.0 Year(s)
2.00 LPA TO 5.00 LPA
Preparation and review the dossier of as per current prescribed guidelines of the respective regulatory authority.
Well versed with the guidelines of ICH and other regulatory.
Preparation of documents for license application.
Preparation of documents for COPP, FSC and other legal documents including product permission
Preparation of registration documents as per ACTD , CTD ...
1 Opening(s)
2.0 Year(s) To 10.0 Year(s)
2.00 LPA TO 5.00 LPA
Preparation and review the dossier of as per current prescribed guidelines of the respective regulatory authority.
Well versed with the guidelines of ICH and other regulatory.
Preparation of documents for license application.
Preparation of documents for COPP, FSC and other legal documents including product permission
Preparation of registration documents as per ACTD , CTD ...
1 Opening(s)
2.0 Year(s) To 10.0 Year(s)
2.00 LPA TO 5.00 LPA
Preparation and review the dossier of as per current prescribed guidelines of the respective regulatory authority.
Well versed with the guidelines of ICH and other regulatory.
Preparation of documents for license application.
Preparation of documents for COPP, FSC and other legal documents including product permission
Preparation of registration documents as per ACTD , CTD ...
6 Opening(s)
3.0 Year(s) To 10.0 Year(s)
5.00 LPA TO 7.00 LPA
DMF API Submission experience is must
Preparation of New Drug Master Files as well as DMF amendments for Brazil, US, and ROW market according to respective agencies requirements.
Preparation of Applicant part of DMF for Brazil, US, and ROW market.
Preparation of all administrative statements for respective authority requirements.
Drafting of regulatory response for ...
1 Opening(s)
3.0 Year(s) To 10.0 Year(s)
3.00 LPA TO 5.00 LPA
Require engineer experience of break down & trouble shooting, routine repairs and maintenance activities of all Formulation equipment's.
Required experience of vial & ampoule line equipment's of injectable facility, handling maintenance of machines like Vial washing, Vial Filling & sealing machine, Rotary washing, Filling & Sealing, Dry Powder Line, inspection & ...