Regulatory Affairs
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.
In case you find this job opportunity interesting and matching to your candidature, you can apply through website or can send your resume on hr@flagshipbiotech.com
HR
Regulatory Affairs
FDA Liasioning
Legal Executive
Sales Profile
Product Management
Documentation Engineer
Marketing Fresher
Packing Supervisor
