Owner at The Career Destination
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Regulatory Affair Role - Pharma (3-8 yrs)
-Dossier preparation, compilation and dossier filing in various regulatory agencies of European/South African Union countries.
- Proficient in dossier submission for Europe market and South African market handling of life cycle management in regulatory affairs.
- Preparation & submission of renewal package application.
- Submission of Post Approval Changes
- Responses to deficiencies received from authorities.
- Review and filing of dossier received from contract manufacturer.
- Review of prototype & technical documents (Mater formula card, Batch manufacturing record, Batch packing record, Process validation report and stability data etc.) for compilation into dossier.
- Preparation of monthly report and deliver monthly presentation of this report by team head to inform regulatory /production/QA functions of the submission made to authority.