Temporary role open in the AbbVie Regulatory Affairs team

AbbVie

  • Oslo
  • Midlertidlig
  • Fulltid
  • 10 dager siden
Are you passionate about driving changes that impact patients' lives worldwide?At AbbVie, our mission is focused on advancing innovative therapies and placing patient well-being at the heart of everything we do. We are now seeking another talented professional to join our Regulatory Affairs team.As a member of Regulatory Affairs, you'll contribute by managing regulatory activities ensuring new product registrations and maintaining existing marketing authorizations, collaborate with cross-functional experts, and make meaningful contributions to regulatory strategy and compliance -- all with patients in mind. If you're committed to excellence, eager to make a real-world difference, and looking for a place where your work genuinely matters, AbbVie's Regulatory Affairs is your next career destination.The candidate will join the Scandinavian Regulatory team as Regulatory Affairs Manager for Norway, reporting to the Head of Regulatory Affairs Norway and Denmark. This is a temporary position, estimated start 1 Nov 2025 and ending on 31 Dec 2026, with the possibility of extension due to maternity leave.Responsibilities include:Lead assigned products regulatory activities in Norway/Scandinavia in collaboration with the Head of Regulatory AffairsManage new product registrations, variations, and maintain compliance of marketing authorizationsTranslation of Product Information and Instruction for Use within given timelinesArtwork development in Electronic Review System (review and approval).Prepare and/or update the abbreviated version of the SmPC (Felleskatalogen)Update and maintain AbbVie regulatory databases and tracking logs.Ensure correct and timely communication with internal stakeholders of new Product Information and abbreviated version of the SmPC used in marketing material.Collaborate with Scandinavian/affiliate brand teams, local regulatory authorities, and other stakeholders to advocate for regulatory strategies, objectives, and timelines.Promotion control -- review and approval of marketing material. Ensure promotional material developed is in line with local regulation and Pharma Code of Conduct (local/Scandinavian).Engage with regulatory policymakers and professional associations to stay informed about trends and changes in national and EU legislation.Qualifications:Cand. Pharm., M.Sc., Cand. Scient or equivalentExperience in Regulatory Affairs and/or promotion control, preferred but not requiredGenuine interest in developing and maintaining expert knowledge for Regulatory Affairs and assigned therapeutic area/product in generalGenuine interest paying attention to details, work structured and follow timelinesFluency in written Norwegian to facilitate translations of product information and instructions for useExcellent written and spoken communication in EnglishStrong commitment to compliance with the relevant rules and procedures, and to scientific quality and integrityCollaborative, team-oriented approach, able to develop and support relationships across the organizationProject management skills, and the ability to get things doneFlexible and able to deal with ambiguityHigh customer orientationWe offer:A passionate focus on the professional and personal development of our employeesGreat career opportunities in a large, international companyA large Scandinavian Regulatory team with highly skilled employeesA dynamic workplace based on respect, where involvement from our employees is strongly encouragedA stimulating and flexible workplace where life-navigation is an integrated part of our work cultureCompetitive benefit packagePlease send your application as soon as possible, and no later than Sept 12th.
We review applications and schedule interviews on an ongoing basis.If you have any questions regarding the position, please reach out to Inger Lise Gruener (Head of Regulatory Affairs, Norway and Denmark).Om bedriftenAbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow.AbbVie is one of the world's largest and leading manufacturers of new and innovative medicines. The patient focus is strong and the company is committed to developing specialized medicines that are aimed at unsolved health problems, especially chronic diseases. Globally, AbbVie has 50,000 employees and is represented in 175 countries.AbbVie is committed to creating conditions for each employee based on the premise that motivated and committed employees create a good workplace and good results. The company has been voted Norway's best workplace several times, and has been among the 10 best Norwegian workplaces for more than 10 years. In Norway, AbbVie AS has around 70 employees, and is located in beautiful premises in Lilleaker.For more information, see www.abbvie.noSektorPrivatNettsted

AbbVie