1 Opening(s)
4.0 Year(s) To 5.0 Year(s)
3.00 LPA TO 4.00 LPA
Duties and Responsibilities :
Collect and coordinate information and prepare regulatory documentation for submission to regulatory agencies or to commercial partners, advise on the submission strategy
Timely compile materials for license renewals, updates and registrations
Maintain regulatory files/database and chronologies in good order. Establish and maintain system for tracking changes in documents submitted ...
1 Opening(s)
1.0 Year(s) To 3.0 Year(s)
2.40 LPA TO 3.00 LPA
Job responsibilities:Preparation, Compilation and review of registration dossier of tablet /capsule/injection in CTD,ACTD as well as country specific format for countriesPreparation, Compilation and review of registration dossier of capsule/syrup/balm in a Herbalproducts for country specific format in countries of African Region, Cambodia, Myanmar, CISTo manage new registration / preregistration / ...
1 Opening(s)
1.0 Year(s) To 2.0 Year(s)
2.20 LPA TO 2.80 LPA
Job Location : Mahape, Nearest Station Ghansoli (Navi Mumbai)
Look for people from Navi Mumbai or Mumbai Only
Only Female Candidates required
Qualification : B.Pharm / M.pharm
Experience : 1yr – 3yr
Salary : 1.42lpa – 2 .80lpa
Profile :
Experience in preparing Dossiers in CTD, ACTD, Country Specific Dossiers.
Countries : ROW and Latum
Job Description:
Dossier Preparation along ...
1 Opening(s)
1.0 Year(s) To 5.0 Year(s)
1.80 LPA TO 4.20 LPA
Dossier preparation as per the ACTD & CTD (Module I, II, III, IV and V) guideline.
Technical documents like Raw Material and finished products specification, manufacturing process,
Product development report, stability reports, process validations preparation & review.
Analytical method validation review as per the ICH guideline.
Drug Master File review
Technical query response to the ...