* Reviewing Marketing Authorization Application (MAA) dossiers and liaising with the RA department at the company’s headquarters in India.
* Supporting existing and potential clients with regulatory / technical information about company products.
* Preparing and submitting dossiers to health authorities in EU countries using national and decentralized procedures.
* Contacting European health authorities to follow up on submissions.
* Communicating with European customers to develop RA strategies and coordinate submissions.
* Reviewing and submitting response documents to deficiency letters from health authorities.
* eCTD publishing.
* Ensuring proper maintenance of dossiers, including PSUR submissions, variations, and renewals.
* Keeping up to date with the latest regulatory requirements in the region.
* Performing selected pharmacovigilance activities.
* Providing support for the development of quality agreements and product release.
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