• 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.• Proposing, developing, and implementing new standard operating procedures. anglès (parlat c1 - d.funcional, escrit c1 - d.funcional)