- Expertise in regulatory filings and approval processes of various drug products in US & Canada Market Experience of compilation of Annual Reports in US & Canada Market.
- Review & compilation of dossier for filing to Regulatory agencies (US & PEPFAR) in eCTD format.
- Compilation of Annual Reports in US & PEPFAR.
- Reviewing, assessing and managing the technical documents needed for regulatory submission.
- Filing of post approval variations (Product Life Cycle Management).
- Evaluation of proposed quality change controls through Trackwise.
- Accompany to regulatory counterparts for compilation of various regulatory submissions, post approvals, Site transfer, Cost saving projects.
- Ensure that all work is in compliance with all pertinent SOP, GLPs and Safe Work Practices.
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