Regulatory Affairs Specialist III

5 months ago


Oslo, Norway Thermo Fisher Scientific Full time

We are currently seeking a  Regulatory Affairs (RA) Specialist  to join Biosciences Division Regulatory Affairs Team. As a member of the RA team, you will be planning, managing, and tracking of regulatory CMC submissions and regulatory documentation, including Drug Master Files for raw, ancillary, and starting materials used in the manufacturing of cell and gene therapies.

Key responsibilities:

Support of activities at Thermo Fisher Scientific site(s) located in Norway for the bead-based technology products and processes (part time). Serving as the liaison between Research scientists and key cross-functional partners, including Regulatory Affairs, Quality Control, Manufacturing Sciences, Product Management, and IP Legal. Collecting, consolidating and ensuring accuracy of documentation required for regulatory support in target markets (EU, US, and other global markets). Creating and maintaining up to date product technical documentation - Master Files. Reviewing and approving product labeling and marketing information to assure compliance with the applicable requirements. Providing regulatory support and expertise to new product introduction project teams and different departments. Participating in change control activities by evaluating impact of manufacturing changes on technical documentation and submitting updates to the competent authorities. Developing regulatory affairs internal policies and procedures and providing trainings as and when required. Appropriately handling confidential information.

Requirements for qualification / education / experience:

University degree in life sciences. Familiar with global Health Authority regulations/guidances eg. FDA regulations, ICH and EMA guidelines/directives. Understanding of QMS standards ( ISO 9001, ISO 13485) and GMP requirements. Experience in the field of regulatory affairs and/or in the pharmaceutical or medical device manufacturing company for over 3 years. Abilities to plan, prioritize and coordinate working process independently and with minimal direction. Proficiency with computer programs/systems (MS office, etc.) with demonstration. Ability to learn new systems quickly. Strong analytical skills and problem-solving skills. Ability to coordinate and work effectively with cross-functional teams. Willingness to travel 2-10% of time.

We offer:

The innovative environment of the rapidly growing international company with encouraging working culture and outstanding development possibilities to increase your potential. An opportunity to work in a dynamic global organization and collaborate with expert professionals.

Compensation and Benefits

The salary range estimated for this position based in Lithuania is 2,;EUR to 3, EUR.

At Thermo Fisher Scientific, each one of our 100,000+ extraordinary minds has an outstanding story to tell. Join us and contribute to our singular mission—enabling our customers to make the world healthier, cleaner and safer.

Compensation and Benefits

The salary range estimated for this position based in Lithuania is €31,–€42,

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

    Job SummaryWe are seeking a highly skilled Regulatory Affairs Specialist III to join our Biosciences Division in Lithuania. This role will be responsible for planning, managing, and tracking regulatory submissions and documentation for raw materials used in the manufacturing of cell and gene therapies.Key Responsibilities:Support activities at Thermo Fisher...


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

    About the RoleWe are seeking a highly skilled Regulatory Compliance Specialist to join our team in Norway. As a key member of our global regulatory affairs department, you will be responsible for ensuring compliance with regulatory requirements and guidelines in the Norwegian market.Job DescriptionDevelop and implement regulatory strategies to ensure...


  • Oslo, Oslo County, Norway DNV Full time

    We are seeking a highly skilled SOLAS and Load Line expert to join our team at DNV Maritime. In this role, you will be responsible for providing technical support to ship operators and DNV surveyors on matters related to load line, fire safety, and lifesaving.The ideal candidate will have a strong understanding of SOLAS Chapters II-2 & III and relevant DNV...


  • Oslo, Norway CAE Full time

    Role and Responsibilities CAE is a high-technology company, bringing the digital and physical worlds closer together to create a safer world. Our vision is to be the worldwide partner of choice in civil aviation, defence and security, by revolutionizing our customers’ training and critical operations with digitally immersive solutions to elevate...


  • Oslo, Norway Statkraft Full time

    Company Description Statkraft has been making clean energy possible for over a century. That’s what we offer. 125 years of unrivalled expertise in supplying the world with what it needs most. Because in the fight against climate change, we don’t see renewable energy as part of the solution. We believe it must be the solution. With us, you’ll...

  • Vet Affairs Manager

    7 months ago


    Oslo, Norway Hill's Pet Nutrition Full time

    No Relocation Assistance Offered # 158983 - Oslo, Oslo, Norway Location: Preferably in the Oslo area Travel: 30%, primarily within Norway Reporting to: Nordic Director, Professional & Veterinary Affairs Why Work For Hill's Pet Nutrition: The Hill's Pet Nutrition Values: To help enrich and lengthen the special relationships between people and...


  • Oslo, Norway Organon Full time

    Job DescriptionThe positionIn this global position you will be part of the Global Logistics Services team (GLS), complementing the Global Trade Compliance COE and reporting to the Director Global Trade Compliance (GTC). You will orchestrate processes, align standards and guidelines to ensure compliance with all applicable laws and regulations for import/...


  • Oslo, Norway Thermo Fisher Scientific Full time

    : Assists customers with specialist technical support assessing potential applications of company products to meet customers’ needs via technical presentations and discussions. Provides application data based on customer requirements to demonstrate feasibility of the application. Conducting practical tasks for studies such as DNA and RNA extraction,...


  • Oslo, Oslo County, Norway Euronext Full time

    Euronext is seeking a highly skilled Financial Services Specialist to join our team. As a key member of our regulatory services department, you will be responsible for reviewing and processing debt listing applications, verifying data, and liaising with internal and external stakeholders.The ideal candidate will have excellent attention to detail, strong...


  • Oslo, Oslo County, Norway SLB Capturi Full time

    We are seeking an experienced CE Marking Specialist to join our team at SLB Capturi, a leading carbon capture technology company. As a crucial member of our team, you will play a key role in ensuring compliance with regulatory requirements and contributing to the success of our industrial energy transition projects.As a CE Marking Specialist, you will be...


  • Oslo, Norway DeepOcean Full time

    As a Sub-Contract Specialist you will play a key role in procurement activities, ensuring effective management of subcontractors and suppliers throughout the project lifecycle. You will have the opportunity to work on diverse and challenging projects. We offer a supportive work environment, competitive compensation package, and opportunities for...


  • Oslo, Norway DNV Full time

    DNV SeaSkill is supporting competence building in the maritime industry, by certifying  Maritime simulator systems used for training, assessment and research Learning programmes Competence management systems Training institutions Training platform providers. We develop and maintain competence standards and recommended practices for areas of...


  • Oslo, Oslo County, Norway Ramboll Full time

    About the RoleWe are seeking an experienced Energy Transition Specialist to join our Bioenergy and Power-Generation team at Ramboll. This is a client-facing role that will involve translating customer enquiries into high-quality technical and commercial proposals, developing consulting projects, providing strategic advice to clients, and driving business...


  • Oslo, Oslo County, Norway DeepOcean Full time

    Job DescriptionAbout the Role:We are seeking a highly skilled and experienced ROV Operations Specialist to join our team at DeepOcean. The successful candidate will be responsible for leading complex ROV operations, ensuring the highest standards of safety and efficiency.Key Responsibilities:Lead ROV operations, including planning, execution, 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 Mondelēz International Full time

    About the RoleWe are seeking an experienced Occupational Health and Safety Specialist to join our team at Mondelēz International. As a key member of our Health, Safety & Environment Department, you will play a vital role in ensuring the safety and well-being of our employees and the environment.Job DescriptionThis is a challenging opportunity for a skilled...


  • Oslo, Norway Thermo Fisher Scientific Full time

    : Prepare, review and coordinate regulatory submissions ((Norwegian Medical Products Agency (RA), Ethics Committee (EC), EU CTR part II submissions), additional national applications if applicable, gene therapy approvals, IVDR/MDR) in alignment with global submission strategy. Provide local regulatory strategy advice (RA &/or EC) to internal clients ...


  • Oslo, Oslo County, Norway Nexans Full time

    Nexans is a global leader in the cable industry, committed to electrifying the future. As part of our Generation & Transmission business group, we design and manufacture cutting-edge cables for projects worldwide.We're looking for a talented Contract Manager/Specialist to join our Legal & Contracts Affairs Department team in Oslo. In this role, you'll work...

  • Contract Manager

    6 months ago


    Oslo, Norway Nexans Full time

    ONBOARDING YOU TO THE COMPANY At Nexans our global vision is to electrify the future. At our business group ‘Generation & Transmission’ this means designing and fabrication the worlds’ best cables. We deliver EPCI turnkey projects anywhere in the world. This means we have the best tools, equipment and people with competence and skillset to install...

  • Biotech Leader

    4 weeks ago


    Oslo, Oslo County, Norway Work In Biotech Full time

    Senior Director/Vice President, Preclinical Research & Site Operations LeadWe are seeking a highly experienced and inspiring leader to join our Discovery team in driving the development of cutting-edge radioligand therapies for the treatment of solid tumors. As a key member of our leadership team, you will oversee the design of translational strategies and...