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ALK offers an exciting opportunity of working in our Global Regulatory Affairs (GRA) department with lots of interdisciplinary collaboration both internally and externally. GRA counts approximately 50 people and is located in Hørsholm.
As Regulatory Affairs Submission Coordinator, you will have a range of responsibilities within submission activities in ALK. We have 2 positions in 2 separate teams, consisting of 9 and 8 people respectively, including the team manager. You will work closely together with the top motivated team members of the RA-teams.
Furthermore, you will be involved in:
- Collaboration with internal and external stakeholders on all procedural regulatory e-submission activities
- Establishment, compilation and coordination of administrative, non-clinical, clinical and CMC parts of regulatory e-submissions for ALK´s products in different regions (in collaboration with the team members and/or other functional areas)
LEO Pharma, Ballerup
LEO Pharma is recruiting a Project Director to join the Global Marketing Psoriasis team in Denmark.
Your job is to evaluate, prioritize and manage cross-functional Life Cycle Management (LCM) of the topical psoriasis portfolio projects and activities with Research & Development (R&D) and Global Product Supply (GPS). This means that you drive and are responsible for the execution and resource allocation plan for the portfolio with and for all involved stakeholders.
You are also responsible for the on-going LCM initiatives follow ups, creating and maintaining a value driven and timely evaluation for the Topical Psoriasis portfolio and report findings to relevant internal boards and stakeholder, so any corrective actions may be agreed upon and implemented if needed.
Our presence in the Nordic region relates back for decades in supporting the Dairy Industry with innovative and reliable food ingredients, forming part of nutritional and well tasting dairy consumer products sold in the region or exported globally under well-known brand names.
We will now employ a highly technical skilled Dairy Sales Manager to become a member of our dedicated Nordic sales team.
Main Job Tasks and Responsibilities
- To be one of the key contacts towards the Scandinavian dairy industry, representing DuPont N&H.
- Working closely with the Nordic and European dairy sales team, application organisation and the business units.
- Your role is to manage the existing business and identify the key growth opportunities within all dairy product categories at selected Dairy accounts.
LEO Pharma, Ballerup
Do you want responsibility and major opportunities for learning as part of a super team?
If you have some years’ Regulatory Affairs (RA) experience, and you are looking for an opportunity to accelerate your development, this one-year maternity leave cover could be the chance you have been waiting for.
You can look forward to a very diversified job with multiple contacts across the global organisation and to external partners. You will be working closely with the Regulatory Labelling Specialists and will be involved in operational/compliance activities e.g. interface to Artwork/supply chain for implementation of labelling changes, handling of EU SmPC/PIL for CP and MRP/DCP in our documentum system, incl. linguistic review within the CP, KPI (Key Performance Indicators) compliance tracking and deviation handling. In addition, coordinate readability testing of Patient Information Leaflets (PILs).
Unomedical A/S, Osted
Som QA Coordinator vil du indgå i mange af virksomhedens processer, hvor du vil være en af kvalitetafdelingens repræsentanter og herved bidrage til vedligeholdelse af virksomhedens compliance niveau iht. regulatoriske, kunde- og corporate krav.
Du vil indgå i QA teamet, som pt. består af 4 medarbejdere, der alle har et tæt samarbejde med både R&D, projekt- og procesafdelingen samt produktionsenhederne i Danmark og Mexico. Vi er certificeret iht. ISO 13485:2016 samt MDSAP.
- NC / CAPA sagsbehandling inkl. root cause analyser og board-møder
- Support til productionen iht. kvalitet issues relateret til non-conforming produkter
- Uddannelse og træning af kollegaer inden for kvalitetsområdet
- QA support til Supply Chain projekter (change management)
Join a leading applied industry research unit to drive product research post launch and regulatory compliance within audiology for Oticon with reference to the Chief Audiologist.
The position has two main responsibilities as indicated above. For the post-market research:
- Establish regulatory rationales and tactics for the area
- Establish Post-Market Clinical Follow-up plan, including studies
For the Audiology compliance part:
- Create, monitor and update processes related to research and other evidence-based audiological activities in Oticon
- Guiding the commercial organization on good practice with regard to claims. This includes guidelines, teaching on the link between claims and evidence, review of selected materials and sparring with stakeholders.
Cook Medical, Bjæverskov
Cook Medical is looking for two Clinical Project Coordinators to participate in conducting clinical investigations of medical devices in Europe. If you like working in an international environment, you might be interested in this position. In the Clinical department, we are responsible for coordinating clinical investigations in Europe. We conduct investigations within most Cook Medical Divisions among others the Vascular Division.
As a Clinical Project Coordinator your responsibilities will be as follows:
- Preparing and electronically archiving study-related documents in cooperation with study team members
- Quality review study documents
- Preparing patient binders and study material
Are you passionate about formulation, process development and manufacture of solid dosage forms?
Novo Nordisk, Måløv