20/04 The Recruiter
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Regulatory Affair Role - Pharma (3-8 yrs)

Mumbai Job Code: 14246

-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.

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