Karo Healthcare

Local Regulatory Affairs Manager

Posted: 18 hours ago

Job Description

Karo Healthcare, a dynamic and growing personal-care retail company, is all about making smart choices for everyday healthcare. With a wide-ranging portfolio across seven categories including medical products, we own and sell over 80 brands in about 90 countries. Our portfolio includes such brands as E45, Pevaryl, Lamisil, Nutravita, Decubal and many others. Our core belief in empowering people to make intelligent health decisions drives our growth strategy, blending organic expansion and M&A.Join us at Karo Healthcare on our exciting journey. We're currently looking for a Local Regulatory Affairs Manager Scandinavia (Norway) for our office in Oslo, Norway.What's in it for you?At Karo, you'll step into a broad, hands-on role with real impact. You'll work at the heart of an international, fast-paced business where regulatory excellence meets commercial growth. This is your chance to:Take ownership of the active Norwegian regulatory portfolio for known products such as IBUX, Paracet and AsanShape processes and strategies that directly influence product access and availabilityCollaborate cross-functionally with local market teams and global functionsGrow your career within a dynamic, ambitious companyWhat you'll be doingAs Local RA Manager Scandinavia in Norway, you'll be responsible for driving regulatory activities across Norway with a broad portfolio across all classifications. Your role is both strategic and operational - balancing compliance with business impact:Ensure timely planning, preparation, submission and follow-up of regulatory activities in Norway on all classifications tasks such as:Life cycle management of Pharma productsHandle communication with different authorities as neededReviewing AW's and, as needed, commercial materialLead local projects from a Regulatory Affairs perspective, connecting the dots across functions and markets. Here you'll directly be a key stakeholder in our growing business by:Giving key input on how to clear a path of access to the market for various productsOverseing local roll-out of Global NPDs/EPDs/GeoX projectsDo Smart risk assessment - to balance both the needs of our great commercial colleagues and complianceSecure compliance in Veeva RIM system and GLAMS AW system (artwork)Ensure product information, translations, and artwork meet regulatory requirementsKeep national databases and product monograph websites updatedPartner closely with Global RA for alignment on globally managed products present in ScandinaviaWe encourage you to take part in commercial activities in Norway. That could be on-site training of customers in products, helping out with stalls at conferences or other non-RA activity where you keep a finger on the pulse, connect with customers and consumers to ensure that our compass is always pointing at true North.RequirementsWe're looking for a structured and collaborative RA professional who thrives in fast-moving environments:University degree in Life ScienceSolid understanding of regulatory requirements and legal frameworks in NorwayMinimum 5 years of experience in Pharmaceuticals is a must. Experience in the other classifications is appreciated but not necessary. We, as a local team, will ensure you are onboarded and trained in non-pharma classifications and will support throughoutExperience with artwork maintenance and label requirementsStrong cross-functional collaboration across Scientific Affairs, Operations, Commercial, and external stakeholdersSolid working relationship/experience with regulatory authorities, experience with the Norwegian authorities is a plusFluent in Norwegian and EnglishPersonal traits that set you up for success:Strong communicator, both written and verbalProactive, service-minded, and solutions-orientedCommercially aware, with a business-driven approach to regulatory challengesFlexible, open-minded, and collaborative, with the ability to see the big picture and challenge the status quoHighly diligent, trustworthy, and skilled at prioritizing and driving tasks independentlyBenefits Opportunity to create, grow, and encourage Apart from a competitive salary pack, there are lots of growth opportunities to meet your personal ambitions Flexible schedule, hybrid model with the primary work place in the office, and life-work balance Responsibility for exciting and challenging projects that have a direct, visible impact on our customers and the industry Very positive work environment in a dynamic, international, and motivated team Start-up spirit while being a part of the large international organization with strong values    Karo Healthcare has a Diverse & Inclusive environment. We are looking for qualified candidates irrespective of gender, gender identity, sexual orientation, ethnicity, race, religion, national origin, disability or age.

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