Regulatory Publisher

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. The role:We are looking for an experienced Regulatory Publisher to compile and manage our global regulatory submissions within the growing Submission Management Group. This role offers the opportunity to build the function and become Camurus' leading expert in Regulatory Publishing.Submission Management is responsible for key operational activities in connection with compilation and submission of marketing authorisation applications worldwide, as well as regulatory data management. You will help define the role, establish ways of working and develop efficient publishing processes at Camurus. Working hands-on in Veeva Publishing, you will collaborate closely with colleagues across functions to ensure high-quality submissions. The role has a global remit, supporting submissions in regions such as US, Europe, Canada, the UK and Australia. As Camurus launches more products, Regulatory Publishing will become an increasingly business-critical and prioritized area. Your key responsibility:As an experienced Regulatory Publisher, your main areas of responsibility will be:Global operational activities related to compilation and publishing of Regulatory dossiers (initial applications, variations, renewals, PSUR etc.), including:Compile regulatory documents into technically correct, submission-ready dossiersContribute to Regulatory strategy discussions by provide Publishing expertise on publishing standards and technical requirementsActing as the coordinating link that brings all parts of a submission together in close collaboration with cross-functional submission teamsLeading, prioritizing and following up on team deliverables in collaboration with the Team Lead, Submission Management Your profileAt least 5 years of professional experience in the pharmaceutical industry, including at least 3 years of regulatory publishing experienceGood knowledge of relevant legislation and regulatory requirementsSolid experience with publishing tools and electronic document management systemsHighly accurate, structured and detail-oriented, with a strong focus on quality and project managementService-minded and collaborative, with the ability to build trust and support colleagues across functionsSelf-driven, with a positive attitude, comfortable taking ownership in a fast-paced environment with tight deadlinesExcellent oral and written communication skills in EnglishBachelor’s or Master’s degree in Science, or equivalentA strong personal drive and a solution-oriented mindset, you support change and can adapt to new conditionsAnalytical, goal-oriented and a strong finisher Camurus offersThis 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. With launches in an increasing number of markets and an exciting pipeline of products in development, regulatory Publishing will be central to Camurus’ continued expansion. The position offers varied work across submissions of different sizes, complexities and regulatory requirements, as well as the opportunity to develop the function, deepen your expertise in Veeva Publishing and continue to grow within Regulatory Publishing. 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 applicationCamurus is partnering with Case Consulting for this recruitment. We review applications and conduct interviews on an ongoing basis. Please send your CV to mg@caseconsulting.se no later than 26 October. For further information about the position, please contact Martin Godaly at +46 (0)708 700 183 or mg@caseconsulting.se. For more information about Camurus, please visit www.camurus.com.We look forward to receiving your application!