Senior Regulatory Affairs Manager - Camurus (Lund)

Camurus is an international, science-led biopharmaceutical company committed to developing and commercializing innovative, long-acting medicines for improving the lives of patients with severe and chronic diseases. New drug products with best-in-class potential are conceived based on the company’s proprietary FluidCrystal® technology and its extensive R&D expertise. The R&D pipeline includes products for the treatment of dependence, pain, cancer, and endocrine diseases. Camurus has operations across Europe, the US, and Australia, with headquarters in Lund Sweden. The company’s shares are listed on Nasdaq Stockholm under the ticker CAMX. For more information, visit www.camurus.com and LinkedIn. At Camurus you will get the opportunity to work with committed colleagues in a fantastic Regulatory Affairs team with good atmosphere and supportive colleagues. Camurus is an innovative company currently expanding and establishing in new markets. In this position you will be part of the Regulatory team, based at the headquarters in Lund. The team today consists of 15 colleagues working with regulatory affairs activities, covering all existing and potential Camurus markets. You will work in a deadline-driven and international environment requiring a high level of flexibility. This is a key position where you will support marketed products. You will get the chance to work with different markets like EU and rest of the world. You will lead critical regulatory activities, ensuring compliance and facilitating effective communication with health authorities. You will be expected to quickly become a working part of the team. Your responsibility: · Lifecycle and maintenance activities for marketed products. · Maintaining core labelling, preparing and maintaining local labelling. · Contributing to and leading health authority interactions. · Monitoring regulatory intelligence information on a regular basis. · Represent Regulatory Affairs (RA) in the cross-functional teams and drive the regulatory agenda, raise RA concerns and opportunities. Candidate profile We are looking for a candidate with at least 10 years professional pharma industry experience, and at least 5 years regulatory affairs experience, preferably from a global RA team working with US and EU markets. This means you have good understanding of relevant regulatory-related regulations and guidelines. You have a Bachelor or Master of Science degree. Excellent communication and documentation skills (oral/written) in English is required, together with project management skills. To be successful in this role, you need a structured and organised mindset with strong focus on details and time management. You are good at independently managing multiple ongoing projects, but at the same time you enjoy working in a team. Even though you are highly structured, you support change and can adapt to new conditions. We value a supportive and flexible “roll up the sleeves” attitude. You see solutions rather than problems and you possess a strong personal drive. We also believe you have the “maintenance mindset”, crucial for working with products already on the market. Camurus offers This is a great time to join a highly dynamic company during an exciting phase of growth. Camurus has been very successful in bringing pharmaceutical products to the market - and the ambitions are to continue in the same way. With a diversified project portfolio in different stages, the commercial potential is considerable. This position offers a fantastic opportunity to work in a competent and committed Regulatory team – where the laughter is never far away. Camurus has 300 employees with the headquarters located in Lund. The corporate culture is driven by the core values of innovation, collaboration, ownership, quality, and passion for realizing a patient-centric commitment. Information and application For more information about this job-opening, please contact recruitment consultant Tobias Lorentzon at TOBLOR Consulting, phone: +46 735 11 10 60. You apply for this position through TOBLOR’s career site, https://career.toblor.se/, by uploading your CV and personal letter. For more information about Camurus, please visit: www.camurus.com/. We are looking forward to seeing your application!