Diligent and dedicated Deputy Manager with 12 years of experience in industry. Excellent interpersonal and communication skills. Dynamic and determined with exceptional leadership qualities.
- Prepare, review and submission of CTD & eCTD for US market with co-ordination activities with CFT team members.
- Review various technical documents line DMF, dossiers.
- Day to day follow up with team members with RA related activities.
- Regularly updating of requirements from regulatory authorities.
- Discussing with regulatory agencies to facilitate approvals.
- Involve in post approval supplements.