Collate/prepare and file dossiers in a timely and accurate manner for formulations & API products to get
licenses from various targeted markets.
2. Review & regulatory impact analysis of the change control, communication with customer for notification and
approval as applicable
3. Review & regulatory impact analysis of the changes notified by the vendors as per current regulatory
requirements (country specific),as desired.
4. Evaluate any changes proposed post-approval. Prepare and file necessary amendments/supplements/annual
reports as applicable to ensure regulatory compliance (Post approval Life Cycle Management).
5. Prepare the checklist for documentation for regulatory fillings as per current regulatory requirement (country
specific)
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