Regulatory Affairs Specialist

2 weeks ago


Oslo, Oslo County, Norway Thermo Fisher Scientific Full time

We are seeking a skilled Regulatory Affairs Specialist to join our Biosciences Division Regulatory Affairs Team.

Key responsibilities:

  • Support activities at Thermo Fisher Scientific sites in Norway for bead-based technology products and processes.
  • Collaborate with Research scientists, Regulatory Affairs, Quality Control, and other cross-functional partners.
  • Collect and consolidate documentation for regulatory support in target markets.
  • Create and maintain product technical documentation, including Master Files.
  • Review and approve product labeling and marketing information.
  • Provide regulatory support to new product introduction project teams.
  • Participate in change control activities and develop regulatory affairs internal policies.

Requirements:

  • University degree in life sciences.
  • Knowledge of global Health Authority regulations and QMS standards.
  • Experience in regulatory affairs and/or pharmaceutical or medical device manufacturing.
  • Strong analytical and problem-solving skills, with ability to work independently.

We offer an innovative environment, encouraging working culture, and outstanding development possibilities.

The salary range for this position is €31,000 to €42,000 based in Lithuania.



  • Oslo, Oslo County, Norway Thermo Fisher Scientific Full time

    Regulatory Affairs Specialist IIIWe are seeking a highly skilled Regulatory Affairs Specialist III to join our Biosciences Division Regulatory Affairs Team. As a key member of the team, you will be responsible for planning, managing, and tracking regulatory CMC submissions and regulatory documentation, including Drug Master Files for raw, ancillary, and...


  • Oslo, Oslo County, Norway Thermo Fisher Scientific Full time

    Regulatory Affairs SpecialistWe are seeking a highly skilled Regulatory Affairs Specialist to join our Biosciences Division Regulatory Affairs Team. As a key member of the team, you will be responsible for planning, managing, and tracking regulatory CMC submissions and regulatory documentation, including Drug Master Files for raw, ancillary, and starting...


  • Oslo, Oslo County, Norway Thermo Fisher Scientific Full time

    Country Approval SpecialistAt Thermo Fisher Scientific, we are seeking a highly skilled Country Approval Specialist to join our team. As a key member of our regulatory affairs team, you will play a critical role in ensuring the successful execution of our global submission strategy.Key Responsibilities:Prepare, review, and coordinate regulatory submissions...


  • Oslo, Oslo County, Norway Thermo Fisher Scientific Full time

    Country Approval SpecialistAt Thermo Fisher Scientific, we are seeking a highly skilled Country Approval Specialist to join our team. As a key member of our regulatory affairs team, you will play a critical role in ensuring the successful approval of our products in the country.Key Responsibilities:Prepare, review, and coordinate regulatory submissions with...


  • Oslo, Oslo County, Norway Hill's Pet Nutrition Full time

    Job Title: Veterinary Affairs SpecialistHill's Pet Nutrition is seeking a highly skilled Veterinary Affairs Specialist to join our team. As a key member of our commercial team, you will be responsible for driving veterinary nutrition growth through relationship building and influence of veterinary specialists, key thought leaders, healthcare teams, and...


  • Oslo, Oslo County, Norway Statkraft Full time

    About StatkraftStatkraft is a leading company in the renewable energy sector, with a rich history of over 125 years. Our mission is to renew the way the world is powered, and we're committed to making a positive impact on the environment and our communities.Job DescriptionWe're seeking a highly skilled Regulatory Reporting Specialist to join our Back Office...


  • Oslo, Oslo County, Norway Statkraft Full time

    About the RoleStatkraft has been driving clean energy solutions for over a century. We are seeking a highly skilled Regulatory Reporting Specialist to join our team in Düsseldorf. The ideal candidate will be responsible for validating transactions, clearing and collateral management processes, contract settlements, billing, and regulatory reporting for all...


  • Oslo, Oslo County, Norway Thermo Fisher Scientific Full time

    Regulatory Compliance RoleAs a Country Regulatory Compliance Specialist at Thermo Fisher Scientific, you will play a critical role in preparing, reviewing, and coordinating regulatory submissions with the Norwegian Medical Products Agency (RA) and Ethics Committee (EC). Your expertise will ensure that all submissions align with our global submission...

  • Senior Legal Counsel

    4 weeks ago


    Oslo, Oslo County, Norway Euronext Full time

    Job SummaryWe are seeking a highly skilled Senior Legal Counsel to join our team at Euronext. As a key member of our legal department, you will be responsible for providing expert legal advice on regulatory and commercial matters, including contract law, corporate law, and intellectual property law.Key Responsibilities Provide legal advice to internal...


  • Oslo, Oslo County, Norway CAE Full time

    Role and ResponsibilitiesCAE is a leading provider of training solutions for the civil aviation, defence and security industries. We are seeking a highly skilled Regulatory Compliance Specialist to join our team in Stockholm.The successful candidate will be responsible for ensuring continued compliance with EASA regulations for the devices stationed at...


  • Oslo, Oslo County, Norway CAE Full time

    Job Summary: We are seeking a highly skilled Regulatory Compliance Specialist to join our team in Stockholm, Copenhagen, or Oslo. This role is responsible for ensuring continued compliance with EASA regulations for devices stationed at Nordic training centers. The successful candidate will align activities with established policies and procedures while...


  • Oslo, Oslo County, Norway DNV Full time

    At DNV, we are seeking a highly skilled Risk Management Specialist to join our team. As a Risk Management Specialist, you will be part of a highly competent team, analyzing documentation and assessing its compliance with expectations, rules, standards, or guidelines. This role involves writing or improving procedures and guidelines, which together form a...


  • Oslo, Oslo County, Norway Nordea Bank Full time

    About the RoleWe are seeking a highly experienced Senior IT Security Specialist to join our Access Management team at Nordea Bank. As an Application Owner, you will be responsible for the lifecycle of our applications, ensuring they deliver the required value and outcome to our workforce while maintaining compliance with legal and regulatory requirements.Key...


  • Oslo, Oslo County, Norway DNV Full time

    DNV SeaSkill is a leading provider of competence building solutions in the maritime industry. We certify maritime simulator systems used for training, assessment, and research, as well as learning programs, competence management systems, training institutions, and training platform providers.We develop and maintain competence standards and recommended...


  • Oslo, Oslo County, Norway DNV Full time

    Overview of DNVDNV is a leading global provider of certification, verification, and risk management solutions for the maritime industry.We develop and maintain competence standards and recommended practices for areas of activities where no established regulatory or industry standards yet exist.Your Role in the Governance UnitAs a Simulator Certification...


  • Oslo, Oslo County, Norway Nordea Bank Full time

    Job ID: 26961We are seeking a seasoned IT Security Specialist to join our Access Management team at Nordea Bank. The ideal candidate will have extensive experience working with IAM solutions, delivering infrastructure services to high-volume applications, and understanding identity security best practices in on-premises and cloud environments.About this...


  • Oslo, Oslo County, Norway DeepOcean Full time

    We are seeking a highly skilled Procurement Specialist to join our team at DeepOcean. As a key member of our procurement team, you will play a crucial role in ensuring the effective management of subcontractors and suppliers throughout the project lifecycle.Main Responsibilities:Conduct procurement activities in accordance with governing procedures and...


  • Oslo, Oslo County, Norway Euronext Full time

    We're seeking a skilled Debt Listing Specialist to join our team at Euronext. As a key member, you'll play a vital role in reviewing bond listings on the Oslo Børs and Nordic ABM markets.As a Debt Listing Specialist, you'll work closely with our business side, external partners, and customers globally. Your ability to contribute to effective solutions and...


  • Oslo, Oslo County, Norway DeepOcean Full time

    Job Title: Sub-Contract SpecialistMain Responsibilities:Conduct procurement activities in accordance with governing procedures and processes.Develop and execute subcontract/procurement plans/strategies in both tender and project phases.Lead pre and post contract award activities including RFQ processes, bid evaluation, negotiation, contract award, and...


  • Oslo, Oslo County, Norway Kuehne+Nagel Full time

    Your RoleAs a National Health and Safety Specialist at Kuehne+Nagel, you will be the linchpin in our efforts to maintain and improve safety, health standards within our organization. Your role will be critical in ensuring compliance with local and international regulations, conducting audits, and fostering a culture of continuous improvement.Your...