Director Regulatory Affairs and Quality Assuranc

Camurus is a pharmaceutical company based in Lund, providing innovative, nanoscale drug-delivery systems for new and improved, high-value therapeutics.The company's proprietary technologies are used in internal drug development programs and in collaborations with biotech and pharmaceutical companies worldwide. Camurus is seeking a Director of Regulatory Affairs and Quality Assurance.The position will include responsibility for development, implementation and management of Camurus' regulatory strategy and quality assurance system.The person should be able to provide regulatory leadership for new product development and, together with the rest of each drug development project team, define clinical trials, CMC requirements and other development processes.An entrepreneurial spirit together with the ability to realize a vision by inspiring and motivating others are key personal characteristics.The main tasks include; -Strategic regulatory responsibility in Camurus' drug development projects -Quality assurance responsibility including implementation and management of Camurus' Quality System -Responsibility of worldwide regulatory registration, notification, pre-market and post-market submission requirements, including the preparation of regulatory documents with appropriate governmental regulatory agencies.-Involvement in regulatory discussions with development partners The position will require extensive strategic Regulatory Affairs experience from drug development and from Quality Assurance for pharmaceutical products and/or medical devices.