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Regulatory specialist and senior specialist

Castro Caldelas (32769)
Actual Talent Spain
Publicada el Publicado hace 18 hr horas
Descripción

Actual Talent is a talent acquisition consultancy that offers Executive Search, RPO and Talent Solutions. We do this through talent acquisition and development solutions that focus on people, diversity and inclusion, innovation, and cutting-edge technology. We are working with a leading European specialty pharmaceutical company focused on the treatment of central nervous system (CNS) disorders, including both psychiatric and neurological disorders. We are currently seeking a Corporate Regulatory Affairs (RA) Specialist. The position is based in Barcelona and offers a hybrid work model. The main focus of the role is to prepare, manage, and submit regulatory documentation to Health Authorities and customers in both European and non-European markets, ensuring full compliance with regulatory requirements, internal procedures, and quality standards throughout the product lifecycle. Prepare, manage, and submit Quality and Labelling variation packages, providing regulatory expertise to support product registration and lifecycle management. Compile and manage documentation for Marketing Authorization Transfers (MAT) across multiple markets, in close collaboration with cross‑functional teams (Supply Chain, Commercial, Quality, PV, International Trade). Manage and maintain regulatory records, submissions, and product files to ensure compliance and audit readiness. Support submissions, variations, renewals, notifications, and post‑approval activities, including timeline tracking, responses to authority questions, and compliance with post‑approval commitments. Support audits, inspections, and customer requests (due diligences, deficiencies, CPPs, statements, samples), and review and approve artwork to ensure regulatory compliance. Strong knowledge of MS Office (Excel, Power Point, Word). Knowledge of database management (Open Text). Knowledge of e-CTD software (Liquent). Language: English and Spanish (fluent) and French (desirable). Bachelor’s in pharmacy or chemistry.

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