Regulatory Affairs Officer - DCGI Market

Role & responsibilities

1. Share the Checklist of documents required for Product Dossier for India Market.
2. Review of regulatory documents received from various stakeholders.
3. Compilation of dossiers as per the country regulations [DCGI/ CDSCO] for various types of applications (CTA/ MA /Import & Registration etc), for submission to Regulatory Authority in India.
4. Application in Form CT-21, Form CT-04, Form CT-05, Form CT-18, Form 40, Form CT-16 on Sugam Portal / NSWS Porta for various permission/approvals from DCGI.
5. Ensure quality of dossier as per DCGIs applicable checklist and ensure timely submission for product approval.
6. Gap analysis of filling dossiers, and closing identified gaps satisfactorily.
7. Review of queries received from Regulatory Body.
8. Ensure quick turnaround time to reply to the queries /deficiencies.
9. Ensure technically sound responses, to avoid repeated queries and ensure faster approvals.
10. Updating the Project Database & Ensure Product Lifecycle Management in terms of Compliance of Regulatory Updates, Renewal of licenses, Product Labels and Post approval compliance.
11. Conduct Due Diligence of Product Dossier for suitability.
12. Review and approval of change controls, CMC documents [specifications, stability data, Validation protocol & reports etc.] and artworks.
13. Review of clinical documentation of PI/Medical Rational/ Investigators Brochure/Protocols/ and other documentation to support dossier submission to DCGI/CDSCO.
14. Regulatory submissions of Clinical Trial Site Documents & Ethics committees.
15. Regulatory Support for the Pharmacovigilance & Safety Reporting Activity.