Regulatory Affairs Specialist

Job description

We Are Teva We’re Teva, a leading innovative biopharmaceutical company, enabled by a world-class generics business. Whether it’s innovating in the fields of neuroscience and immunology or delivering high-quality medicine worldwide, we’re dedicated to addressing patients’ needs now and in the future. Here, you will be part of a high-performing, inclusive culture that values fresh thinking and collaboration. You'll have the room to grow, the flexibility to balance life with work, and the opportunity to better health worldwide, together. Role Summary We are seeking a Regulatory Affairs Specialist to manage and support regulatory activities for pharmaceutical products on the Romanian market, ensuring compliance with national (ANMDMR) and EU regulations. Key Responsibilities: - Prepare and manage regulatory submissions (national, variations, renewals) - Maintain product licenses and regulatory documentation for medicinal products - Monitor regulatory changes and assess impact on registered products - Support launches, lifecycle management, and compliance activities - Translations / coordination of translations with an agreed supplier for specific documents from Romanian into English and...