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 / ...
2 Opening(s)
3.0 Year(s) To 4.0 Year(s)
6.50 LPA TO 8.00 LPA
Role:
• Preparation and review of Electronic Common Technical Document (eCTD), PSUR. PADER or RMP in compliance with EU and US standards and protocols.
• Write, edit clinical study protocols. clinical study reports, summary documents, investigator brochures, portions of regulatory briefing documents and development safety update reports.
• Drafting and revising pre-clinical summaries.
• ...
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 ...