Position Title : Executive Regulatory Affairs
Department : Regulatory Affairs
Years of experience required : 1 to 4 yrs
Only Pharma Graduate
Job Details :
- Preparation of dossiers (CTD, ACTD, NEES, Country specific format) including process validation, Product Development report, and Stability data.
- Must have handled ROW market and CIS countries.
- Compilation of documents for eCTD dossier as per EU guidelines.
- Co-ordination and Collection of Dossier data and samples from plant.
- Co-ordination with plant for audit and for specific plant registration.
- Application of COPP and FSC in plant (P2P and LL) and its follow up.
- Commercial product artwork and MPD checking.
- Query solving after submission of products.
- Compilation and preparation of Tender documents/dossier.
- Co-ordination for outsourcing of DMF/Clinical study.
- Follow up from client for submission and registration.
- Checking of Master Manufacturing Documents for different products.
- Preparation of draft for artwork and leaflet.
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