submission

Thermo Fisher Scientific is seeking a Country Approval Specialist to support local regulatory submissions and coordinate with MoH and EC in line with global strategy. You will liaise with internal teams, investigators, and sites to ensure timely, compliant submissions and country-specific patient information materials where needed.The role requires a...

Zealand Pharma A/S is seeking a Regulatory Documentation Specialist to drive the operational delivery of CTA/IND/NDA/MAA/PIP submissions and related documents. You will work closely with RA and cross-functional colleagues, coordinating with CROs and publishers to ensure submission readiness. You will maintain trackers, handle CTIS activities, and act as a...

Lunar Denmark, based in Copenhagen, is seeking a Senior Regulatory Reporting Specialist to translate regulatory frameworks into documented reporting logic and to drive quality review across the reporting perimeter. You will work with CRR, CRD, and EBA guidelines, partnering with product and tech teams to ensure accurate submissions.You'll be part of a...

Novo Nordisk A/S is seeking a Senior Clinical Data Scientist to lead data science activities across global development programmes. You will collaborate with trial teams, regulatory experts, and external partners to ensure high-quality, submission-ready data and documentation. The role includes input on trial design, SDTM/ADaM and TFL deliverables, and...

Novo Nordisk A/S is seeking a Senior Clinical Data Scientist to lead data science activities across global development programmes. You will collaborate with trial teams, regulatory experts, and external partners to ensure high-quality, submission-ready data and documentation. The role includes input on trial design, SDTM/ADaM and TFL deliverables, and...

Novo Nordisk A/S is seeking a Senior Clinical Data Scientist to lead data science activities across global development programmes. You will collaborate with trial teams, regulatory experts, and external partners to ensure high-quality, submission-ready data and documentation. The role includes input on trial design, SDTM/ADaM and TFL deliverables, and...

Novo Nordisk A/S is seeking a Senior Clinical Data Scientist to lead data science activities across global development programmes. You will collaborate with trial teams, regulatory experts, and external partners to ensure high-quality, submission-ready data and documentation. The role includes input on trial design, SDTM/ADaM and TFL deliverables, and...

Novo Nordisk A/S is seeking a Senior Clinical Data Scientist to lead data science activities across global development programmes. You will collaborate with trial teams, regulatory experts, and external partners to ensure high-quality, submission-ready data and documentation. The role includes input on trial design, SDTM/ADaM and TFL deliverables, and...

Novo Nordisk A/S is seeking a Senior Clinical Data Scientist to lead data science activities across global development programmes. You will collaborate with trial teams, regulatory experts, and external partners to ensure high-quality, submission-ready data and documentation. The role includes input on trial design, SDTM/ADaM and TFL deliverables, and...

Novo Nordisk A/S is seeking a Senior Clinical Data Scientist to lead data science activities across global development programmes. You will collaborate with trial teams, regulatory experts, and external partners to ensure high-quality, submission-ready data and documentation. The role includes input on trial design, SDTM/ADaM and TFL deliverables, and...

Bavarian Nordic A/S is seeking a part-time Student Assistant for the Regulatory CMC team in Kvistgård. You will support regulatory information management tasks and help ensure metadata quality in Veeva RIM. The role emphasizes accuracy, collaboration with international colleagues, and learning how regulatory submissions are prepared. You will balance study...

Novo Nordisk A/S is seeking a Senior Clinical Data Scientist to lead data science activities across global development programmes. You will collaborate with trial teams, regulatory experts, and external partners to ensure high-quality, submission-ready data and documentation. The role includes input on trial design, SDTM/ADaM and TFL deliverables, and...

Novo Nordisk A/S is seeking a Senior Clinical Data Scientist to lead data science activities across global development programmes. You will collaborate with trial teams, regulatory experts, and external partners to ensure high-quality, submission-ready data and documentation. The role includes input on trial design, SDTM/ADaM and TFL deliverables, and...

Lunar, a Nordic challenger bank, seeks a Senior Regulatory Reporting Specialist to join the Capital & Regulatory Reporting team in Copenhagen, translating regulatory frameworks into validated reporting logic and driving quality across the reporting perimeter.You will own COREP, Danmarks Nationalbank reports, KRGS, and DFSA submissions, and collaborate with...

Zealand Pharma A/S seeks a Regulatory Documentation Specialist to drive submission operations across CTA/IND/MAA/PIP, ensuring timely, high-quality documents. The role interfaces with RA and cross-functional teams to maintain trackers and CTIS processes.You will coordinate with CROs, publishers and external partners, manage DSUR IB QA activities and support...

Lundbeck is seeking an experienced regulatory medical writer to lead complex documents and advise cross-functional teams in Copenhagen. The role supports the development pipeline by preparing clear, scientifically robust regulatory documents.The lead author will manage document strategy, content, and timelines, collaborating with clinical development,...

Novo Nordisk A/S is seeking a Senior Clinical Data Scientist to lead data science activities across global development programmes. You will collaborate with trial teams, regulatory experts, and external partners to ensure high-quality, submission-ready data and documentation.The role includes input on trial design, SDTM/ADaM and TFL deliverables, and driving...

Zealand Pharma A/S is seeking a Regulatory Documentation Specialist to drive the operational delivery of CTA/IND/NDA/MAA/PIP submissions and related documents. You will work closely with RA and cross-functional colleagues, coordinating with CROs and publishers to ensure submission readiness.You will maintain trackers, handle CTIS activities, and act as a...

Lunar, a Nordic challenger bank, seeks a Senior Regulatory Reporting Specialist to join the Capital & Regulatory Reporting team in Copenhagen, translating regulatory frameworks into validated reporting logic and driving quality across the reporting perimeter. You will own COREP, Danmarks Nationalbank reports, KRGS, and DFSA submissions, and collaborate with...

Lunar ApS is seeking a Senior Regulatory Reporting Specialist to join the Capital & Regulatory Reporting team in Copenhagen. You will translate regulatory frameworks into documented reporting logic, drive quality reviews across the perimeter, and position CRR as an internal SME for Lunar's product and tech teams.You will own regulatory submissions...