Experteer Overview
In this role you ensure regulatory and quality compliance across the medication lifecycle in Spain, from development to post-market oversight. You will lead regulatory tasks, liaise with Health Authorities, and uphold patient safety and product availability. You’ll work within SQR to drive consistent regulatory strategies and risk management across the lifecycle. This is an opportunity to shape regulatory excellence within a global kidney-care leader and contribute to safe, high-quality medicines.
Compensaciones / Beneficios
• Ensure efficient, compliant regulatory processes for Market Authorization, product launches, distribution and sustained availability
• Manage lifecycle regulatory activities including development, registration, post-market surveillance, and supply chain quality with a focus on GDP and PVRP compliance
• Prepare, submit, and maintain regulatory dossiers and documentation per local/regional requirements
• Promote consistent regulatory strategies and collaborate with Health Authorities and stakeholders
• Monitor regulatory changes, support inspection readiness, and provide expert regulatory and quality guidance to internal teams
Responsabilidades
• BA university degree in Pharmacy or related field
• Advanced training in Regulatory Affairs of medicinal products
• 2–4 years in a similar regulatory role
• 2+ years in regulatory affairs in MedTech/Pharma
• 2+ years in regulatory submissions and compliance
• 2–3 years GDP-related experience in pharmaceutical field
• 1+ year pharmacovigilance experience and knowledge of local PV regulations
• Good knowledge of ISO 9001, ISO 13485, and GxP
• Proficiency with regulatory software and document management systems
• High proficiency in MS Office, SharePoint, MS-Teams
• Fluent in English; native language in country; additional languages a plus
Requisitos principales
• hybrid work
• career development opportunities
• integral company benefits
• collegial culture of a medium-sized company
• diversity and inclusion
• competitive compensation