Regulatory Document Specialist

Medical Writing and Clinical Disclosure Professional Job OverviewLEO Pharma is seeking a skilled professional with a passion for medical writing and clinical disclosure to join our Medical Communication team in Global Clinical Development.This role plays a crucial part in planning, managing, and writing clear, concise, and audience-friendly regulatory,...

We are seeking a Senior Regulatory Specialist to join our dynamic Regulatory Affairs CMC team at Genmab A/S.As a Senior Regulatory Specialist, you will be responsible for providing operational and strategic regulatory CMC input to support worldwide development and commercialization.You will work closely with cross-functional teams to ensure compliance with...

We are seeking a highly skilled Regulatory Compliance Specialist to join our Life Cycle Management (LCM) Product team at Sandoz International GmbH. As a key member of our team, you will be responsible for ensuring the regulatory compliance of marketing authorizations across multiple countries and product portfolios.This role requires close collaboration with...

Regulatory and Start Up Specialist - Nordics Apply locations: Solna, Sweden; Copenhagen, Denmark; Espoo, Finland; Oslo, Norway Time type: Full time Posted on: Posted 2 Days Ago Job requisition id: R1470460 Job Overview Perform tasks at a country level associated with Site Activation (SA) activities in accordance with applicable local and/or international...

The Director of Regulatory Affairs at Black Swans Exist is responsible for ensuring that the company's products meet global regulatory requirements, focusing on the USA and Europe. This role develops and executes regulatory compliance strategies, navigates approval processes for pharmaceuticals and medical devices, and ensures timely updates for existing...

We are looking for a highly skilled Financial Regulatory Specialist to join our Finance team at Lunar Denmark. In this role, you will be responsible for ensuring compliance with Danish tax authorities and navigating regulations across the Nordic markets.Your key responsibilities will include gathering and analyzing information from our accounting systems,...

Key ResponsibilitiesThe Quality Specialist role requires a high level of expertise in quality management, regulatory compliance, and process improvement. Key responsibilities include:Ensuring compliance with GDP regulations and local legislation.Managing product and batch release activities for continuous supply.Handling complaints and quality-related issues...

We are seeking a highly experienced Pharma Documentation Specialist to join our team at Think IT Resources. As a Quality Assurance Expert, you will be responsible for establishing and maintaining traceability from documented requirements through design documentation to test execution.Key responsibilities include:Establishing and maintaining...

About the RoleThis is an exciting opportunity to join our team as a Regulatory Affairs Specialist for Site Activation in the Nordics region.You will be responsible for performing tasks at a country level associated with Site Activation (SA) activities, ensuring adherence to local and international regulations, standard operating procedures (SOPs), project...

Key ResponsibilitiesAs a Drug Product Manager, you will have the opportunity to work on a wide range of projects and initiatives, including:Stability Program Management: Develop and implement stability programs to ensure the long-term quality of our drug products.Process Development: Collaborate with cross-functional teams to develop and optimize...

Job Description:We are looking for a skilled Medical Writer Consultant to join our team at Pharma IT. In this role, you will work on-site or remotely with our clients in the pharma, biotech, and medical device industries.Key Responsibilities:Write and review nonclinical documents for regulatory submissions.Work closely with cross-functional teams to deliver...

About the JobWe are seeking a banking professional with expertise in shaping and delivering a robust testing framework within the Conduct, Sustainability, and Regulatory Risk domains at Danske Bank. As the leader of regulatory risk testing, you will play a pivotal role in maintaining the integrity and effectiveness of our control environment.Your key...

About UsDanske Bank is a leading financial institution committed to delivering exceptional customer experiences while maintaining a strong focus on risk management and regulatory compliance. Our Conduct, Sustainability, and Regulatory Risk Testing team plays a critical role in ensuring the integrity and effectiveness of our control environment.About the...

Company OverviewCadeler A/S is a leading provider of turbine and foundation installation services to the offshore wind industry. Our company has developed a successful reputation, having delivered installation services on over thirty wind farms in Europe to clients such as Siemens Gamesa Renewable Energy, Vestas, Vattenfall, and Ørsted.Job DescriptionAs our...

The Director of Regulatory Affairs ensures that the company's products meet global regulatory requirements, focusing on the USA and Europe, including those set by the FDA, EMA, and other relevant authorities. This role is responsible for developing and executing regulatory compliance strategies, navigating approval processes for pharmaceuticals and medical...

About the RoleThe System Documentation Manager will be responsible for operating and maintaining documentation on IT components within Computerized Equipment on our Filling Lines and in the Formulation area. This includes developing and maintaining documentation to ensure compliance with internal and external regulatory frameworks & procedures.As a key...

Job Overview Perform tasks at a country level associated with Site Activation (SA) activities in accordance with applicable local and/or international regulations, standard operating procedures (SOPs), project requirements and contractual/budgetary guidelines. May also include maintenance activities.Home Based role and requires local language proficiency. ...

Job OverviewPerform tasks at a country level associated with Site Activation (SA) activities in accordance with applicable local and/or international regulations, standard operating procedures (SOPs), project requirements and contractual/budgetary guidelines. May also include maintenance activities.Home Based role and requires local language...

Medical Documentation Leadership RoleThis is an exciting opportunity to lead the Medical Documentation department at Lundbeck A/S, H. As the Head of Global Regulatory Affairs and R&D Quality, you will be responsible for driving digital transformation and enhancing R&D productivity through change management initiatives, implementation of innovative digital...

Job DescriptionGenmab's Digital Systems Management team is looking for a skilled system manager to help maintain and develop GenDocs, an enterprise electronic document management system (EDMS) based on Veeva Vault.The successful candidate will have a strong understanding of IT systems management, particularly with EDMS systems and Veeva Vault. They will work...