The Work Activities Will Include Providing Remote Cmc Regulatory Support in the Preparation of Various Submission Dossiers in Collaboration with the Client Team for Investigational and Marketed Pharmaceutical Products.
Candidate with 3-5 year of experience in regulatory filing for ROW and Semi- regulated marked for Injectable Formulation.
Advantage if handled eCTD submission and exposure of Regulated Market and other Dosage form.
Should be capable of handling...
Strong Ethics and Integrity.
knowledge in Ce Marking and Fda
iso 13485, Documentation
strong Technical/functional Knowledge.
4 -8 Years of Experience in Medical Devices
engineering / Be / Biomedical/electronics
ecg, Patient Monitors, Multipara ...
RS 2,00,000 To 3,50,000 Dehradun, Haridwar, Roorkee
Medicinal products, pharmaceuticals, veterinary medicines, medical devices, and food supplements – all these products are subject to regulations designed by governments to protect public health. The Regulatory Affairs departments of life-science co...
Key Skills : drug regulatory affair,regulatory affair,legal officer
Submission of Module 2-3 Variation Filing, Responding Regulatory Queries, Literature Clinical Data
*preparation & Registration of Dossiers as per Country Guidelines and Checklist
*review of Product Development Report, Specifications
RS 1,25,000 To 2,50,000 South Delhi, West Delhi, Delhi
- Preparation of dossier in CTD/ACTD format, Analytical skills for evaluating technical documents.
- Communicating with the different department of Manufacturing Unit (QA, QC,Production etc)
- Handling of NOD / resolving query
1. the Candidate Should Be B.pharma
2. Working Experience in Who Certified Manufacturing Unit is Must.
3. the Candidate Must have Regulatory Work Experience of Preparing
dossiers for Different Countries, Knowledge and Experience of D...