-Compilation and submission of eCTD dossier for current product application (ANDA/EU-MA)/Post approval submission to the regulatory authority (specifically EU/US)
-Hand on experience in preparation of CTD section as per regulatory requirements of different region
-Having experience in preparation of query response and PAS, CBE and annual report.
-Have ability to co-ordinate with cross functional team
-Having experience for Drug listing and annual updates
-Having ability to review documents as per current regulatory guidelines.
- Have experience of compilation of Labelling section of US ANDA/EU MA
-Preparation and review of artwork related to ANDA in line with innovator product
-Maintain product life cycle for Labelling requirement inline with RLD updates
-Submission of labelling SPL through software as per regulatory requirements
-Have hand Ons experience for handling of E-CTD software
📌 Regulatory Affairs (Vadodara)
🏢 Actide International
📍 Vadodara
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