Regulatory Affairs Manager

12 hours ago


Stockholm, Stockholm, Sweden TN Sweden Full time
About the Role

We are looking for a highly skilled Team Lead Pharma Submissions & Compliance, Global Regulatory Affairs to join our team in Stockholm, Sweden.

The successful candidate will be responsible for leading a team to drive maintenance and development of Karo medicinal products. This includes managing Submissions & Compliance activities, ensuring compliance with artwork processes, eRIMS data systems, and archiving.

The role requires overseeing SPOR implementation in Karo's data systems from a regulatory perspective. The candidate will also coordinate and support local RA consultants to ensure compliance with local requirements.

This is an exciting opportunity for someone who wants to contribute to a dynamic, international, and motivated team while working on challenging projects with a direct impact on our customers and the industry.

  • Maintaining current knowledge base of existing and emerging regulations, standards, or guidance documents
  • Providing regulatory input to cross-functional teams/projects
  • Coordinating subsidiaries, partners and consultants on applicable market(s)

The ideal candidate will have a university degree in Life Science and minimum 5 years experience in Global Regulatory Affairs in a similar role.



  • Stockholm, Stockholm, Sweden Bondi Chefrekrytering AB Full time

    Are you passionate about improving patient lives?Bondi Chefrekrytering AB is seeking a highly motivated Senior Regulatory Affairs Manager to join our team. As part of the EU Regulatory Affairs team, you will be responsible for post-approval/life-cycle Regulatory activities in the Nordic markets.Main ResponsibilitiesAct as point of contact with Nordics...


  • Stockholm, Stockholm, Sweden Karo Healthcare Full time

    About UsKaro Healthcare is a dynamic and growing company that empowers people to make intelligent health decisions. We own and sell over 80 brands across seven categories, including medical products, and have a presence in about 90 countries.We are currently looking for a Regulatory Affairs Manager to join our team in Stockholm. As a key member of our...


  • Stockholm, Stockholm, Sweden Karo Group Full time

    Karo Group is a dynamic and innovative company dedicated to empowering people to make informed healthcare decisions.About the RoleWe are seeking an experienced Regulatory Affairs Lead to join our team in Stockholm, Sweden. As a key member of our Global Regulatory Affairs department, you will play a vital role in ensuring compliance with regulatory...


  • Stockholm, Stockholm, Sweden Bondi Chefrekrytering AB Full time

    We are recruiting a Head of Regulatory Affairs to lead our EU Regulatory Affairs team in the Nordic markets. As a key member of our team, you will be responsible for post-approval/life-cycle Regulatory activities.About the RoleIn this role, you will have the opportunity to develop and implement regulatory strategies, ensuring alignment with company...


  • Stockholm, Stockholm, Sweden TN Sweden Full time

    RaySearch is a leading developer of innovative software solutions for cancer care. Our QA/RA team is responsible for ensuring the quality and safety of our medical devices, from development to delivery. We work closely with regulatory authorities to ensure compliance with relevant regulations and guidelines.We are seeking a highly skilled Regulatory Affairs...


  • Stockholm, Stockholm, Sweden Recipharm AB Full time

    We are seeking an experienced Regulatory Affairs Specialist to join our team in RPH Pharmaceuticals. As a Regulatory Affairs Specialist, you will be responsible for supporting our quality management system (QMS) processes, ensuring compliance with Global Quality requirements.The role includes:Managing and leading GxP Training, performing SOP training, and...


  • Stockholm, Stockholm, Sweden TN Sweden Full time

    About TN SwedenWe are a leading provider of medical technology solutions, committed to making life-saving technology accessible for more people. As a Regulatory Affairs Specialist, you will play a crucial role in ensuring our products meet environmental compliance standards.The ideal candidate will have a strong background in environmental science, materials...


  • Stockholm, Stockholm, Sweden Business Sweden Full time

    About UsBusiness Sweden is a government agency working to increase export opportunities for Swedish businesses. We provide strategic advice and hands-on support to companies of all sizes and in a wide range of industries, both locally and internationally.About the RoleWe are seeking a highly skilled International Regulatory Affairs Specialist to join our...


  • Stockholm, Stockholm, Sweden QBtech AB Full time

    **About Us**QBtech AB is a dynamic and innovative company dedicated to improving lives through cutting-edge technology. We offer a unique opportunity to work with a talented team of experts who share a passion for transforming healthcare. If you are a driven and results-oriented individual with a keen interest in quality and regulatory affairs, we encourage...


  • Stockholm, Stockholm, Sweden Galderma Full time

    About the RoleWe are seeking a highly skilled professional to join our team as a Regulatory Affairs & Quality Assurance Officer, focusing on the Nordic region. This role is crucial in ensuring the successful launch of new products, while also maintaining the existing portfolio.


  • Stockholm, Stockholm, Sweden Bondi Chefrekrytering AB Full time

    Company Overview:Bondi Chefrekrytering AB is a leading Swedish medtech company with high potential, committed to innovation and excellence.Job Summary:We are seeking a highly skilled Senior RA Specialist Med Tech to join our team. As a key member of our regulatory affairs department, you will be responsible for ensuring compliance with laws and regulations...


  • Stockholm, Stockholm, Sweden Raysearch Laboratories AB (Publ) Full time

    Job DescriptionWe are seeking a highly skilled QA/RA Specialist to join our team. As a key member of our Quality Assurance and Regulatory Affairs department, you will play a crucial role in ensuring the accuracy and reliability of our medical device software. Your primary responsibilities will include managing QMS transitions, CAPA processes, and...


  • Stockholm, Stockholm, Sweden PharmaRelations ApS Full time

    Leadership OpportunityAs Senior Director Regulatory Affairs, you will have the opportunity to lead regulatory activities, develop and implement strategies, and collaborate with the global team. You will take ownership of regulatory activities, overseeing marketing and ensuring compliance.AccountabilitiesTake ownership of regulatory activities, including MAs,...


  • Stockholm, Stockholm, Sweden PharmaRelations ApS Full time

    OverviewPharmaRelations ApS is seeking an experienced Senior Director Regulatory Affairs to lead regulatory strategies, particularly for OTC products. This is a key role in building a new pharmaceutical portfolio.ResponsibilitiesEstablish and lead regulatory activities across areas including MAs, marketing of cosmetics, medical devices, and food...


  • Stockholm, Stockholm, Sweden SEB group Full time

    Job SummaryWe're seeking a seasoned professional to join our Corporate and Investment Banking division as a Business Regulatory Consultant. This exciting opportunity will leverage your expertise in regulatory affairs, compliance, or a related field to drive end-to-end client communication related to global markets regulations.Key ResponsibilitiesManage...


  • Stockholm, Stockholm, Sweden PharmaRelations ApS Full time

    PharmaRelations ApS, a pioneering leader in the consumer health space, is expanding into the pharmaceutical industry. We are seeking an experienced Senior Director to establish and lead regulatory strategies for OTC products as we build our pharmaceutical portfolio.This role offers the opportunity to shape the future of OTC pharmaceuticals for a company...


  • Stockholm, Stockholm, Sweden PharmaRelations ApS Full time

    About the Role:We are seeking an experienced Sr Director Regulatory Affairs to join our team at PharmaRelations ApS. As a strategic leader in regulatory affairs, you will take ownership of regulatory activities across a range of areas, including MAs (MRP/DCP and national licenses), and oversee the marketing of cosmetics, medical devices, and food supplements...


  • Stockholm, Stockholm, Sweden Karo Group Full time

    Karo Group is committed to making intelligent health decisions through innovation and expertise.About the RoleWe are seeking an experienced Global Regulatory Compliance Officer to join our team in Stockholm, Sweden. As a key member of our Global Regulatory Affairs department, you will play a vital role in ensuring compliance with regulatory requirements and...


  • Stockholm, Stockholm, Sweden Sobi - Swedish Orphan Biovitrum AB (publ) Full time

    About the RoleThis is an exciting opportunity to lead and manage the Computer System Validation (CSV) process, ensuring e-compliance of GxP systems. The successful candidate will have strong leadership skills and be able to motivate and guide a team to achieve compliance goals.Key ResponsibilitiesDefine and maintain corporate CSV standards across the...


  • Stockholm, Stockholm, Sweden TN Sweden Full time

    About the RoleWe are seeking an experienced Environmental Regulatory Compliance Manager to join our corporate sustainability team. The successful candidate will be responsible for monitoring upcoming and existing ESG-related laws and regulations.The ideal candidate will have a strong background in environmental science, materials science, or a related field,...