Posted:4 days ago|
Platform:
Work from Office
Full Time
Collate/prepare and file dossiers in a timely and accurate manner for Formulations and API products to get licenses from various targeted markets (Emerging Markets/ROW).
Review and regulatory impact analysis of the change control, communication with customer for notification and approval as applicable.
Review and regulatory impact analysis of the changes notified by the vendors as per current regulatory requirements (country specific), as desired.
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).
Prepare the checklist for documentation for regulatory fillings as per current regulatory requirements (country specific).
Collate and conduct first-level review/overview of relevant standard technical documentation like stability, TTD, PDR, method validations etc. as per the country requirements.
Conduct initial review of the specifications of the API / Semi-Finished Product / Finished Product as per the regulatory requirements.
Conduct initial review of labelling/artwork as per the market where the dossier is being filed(only formulations).
e-CTD compilation/ publishing of DMF / Dossiers and Submission to customer / Health Authorities.
Assist in resolution of queries received from customer/agency/regulator and assessing them before sharing with team leader.
Sharing copies of all Agency submissions pertaining to API and Approval package for FDF,with respective manufacturing sites.
Submission of Renewals, Re-registrations, Tender (Emerging Markets).
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