17 ago
|
Théa Pharma Spain
|
Barcelona
17 ago
Théa Pharma Spain
Barcelona
About Théa Laboratorios Théa is part of the independent Théa Group, a leading European pharmaceutical company specialized in ophthalmology. We are committed to improving patients' quality of life through innovation, scientific excellence, and the highest standards of regulatory compliance. We are looking for a Regulatory Affairs to join our Spanish affiliate on a fixed-term basis and provide regulatory support for approximately 8–11 months. This position offers a unique opportunity to gain exposure to a broad range of regulatory activities across pharmaceuticals, medical devices, cosmetics, food supplements, promotional review, and lifecycle management within an international environment. Key Responsibilities Reporting to the Technical Director and working closely with both local and Group Regulatory Affairs teams, the successful candidate will: Monitor and assess Spanish and European regulatory requirements applicable to pharmaceuticals, medical devices, cosmetics, food supplements, and pharmaceutical companies.
Support the preparation of documentation required for marketing authorization applications, variations, renewals, responses to authorities, and other lifecycle management activities for medicinal products. Collaborate with Théa Group Regulatory Affairs teams to ensure timely submission and maintenance of registrations in line with corporate regulatory strategies. Assist in the preparation and submission of local regulatory filings related to medical devices, cosmetics, and food supplements to obtain and maintain marketing authorizations in Spain. Support the preparation and maintenance of health licenses, permits, and regulatory authorizations required for the company's activities in Spain. Review promotional and non-promotional materials in collaboration with Compliance, Medical Affairs, and Commercial teams, ensuring consistency with approved product information, marketing authorizations, applicable regulations, industry codes, and internal company polici
📌 Regulatoy affairs (Barcelona)
🏢 Théa Pharma Spain
📍 Barcelona