Posted:1 day ago|
Platform:
Work from Office
Full Time
1. Prepare, compile, and review regulatory dossiers for submission.
2. Respond to queries and deficiency letters from regulatory authorities in coordination with technical teams.
3. Co-ordinating with cross-functional teams like R&D, QA/QC, production to collection of data for submissions.
4. Maintain regulatory files and track submission and approval status using internal systems.
5. Provide regulatory input during product development, scale-up, and lifecycle management.
6. Supporting the review of product labels, cartons, and inserts to ensure compliance with regulations.
7. Ensure products comply with all regulatory requirements through each stage of development and commercialization.
8. Conduct training sessions on regulatory updates and internal System
9. Ensure documentation is audit-ready and aligned with internal SOPs and regulatory expectations.
10. Support internal and external audits by providing required regulatory documents and justifications.
11. Guide and review work of junior team members or trainees.
12. Review and interpret regulatory guidelines and notify stakeholders of relevant updates.
13. Review of all dossiers related technical documents
Experience in reviewing of Analytical documents
Leben Life Sciences
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