6 job matcher din søgning
Symphogen A/S, Ballerup
Symphogen is currently experiencing an increase in activities within both the early and late stage projects. Furthermore, Symphogen is planning to start phase III clinical trials and to apply for a Manufacturing and Import Authorization (§39 Licence).
Symphogen therefore plans to strengthen the QA organization with a Quality Manager.
As Quality Manager you will be involved in every step of the manufacturing process from generation of cell banks, upstream and downstream processes, final formulation, filling, analysis and release of the final drug product. The manufacturing is outsourced to various CMO's in EU and US.
The Quality Manager will participate for the quality group in our projects covering process and analytical validation, PPQ, clinical supply, and eventually marketing application.
Would you like to use your quality competences in a holistic and pragmatic way, by being a part of growing the ALK business and meeting the needs for people with allergy earlier in their allergy journey?
If you enjoy new challenges, where you need to use your professional approach to quality as well as your personal skills to obtain results together with internal and external stakeholders, this is your next position.
In this exciting position, your quality competencies and experience will come into play, as you will be involved in setting the standard for quality activities related to new business opportunities. You will be part of the ALK Global Quality, Markets & Inspections department, an experienced team that works closely on quality aspects with internal and external collaborators from many different cultures.
You will be responsible for preparing, leading and implementing the regulatory development strategies of both small and large molecules for development projects with a high degree of complexity. You will represent RA in the global cross-functional project teams where you will focus on identifying regulatory opportunities and creating regulatory pathways for novel development directions within CNS.
In a typical day, your activities will range from discussing development strategy with the clinical lead, preparing for health authority interactions, looking into evidence generation strategies with your HEOR colleague, chairing a team meeting with your regulatory colleagues from key markets, to presenting a submission strategy for the cross-functional project team and/or Executive Management and Business Partners.
Compass Human Resources Group A/S recruiting on behalf of Sanofi in Hørsholm
With reference to the Franchise Lead Rare Disease you will take on the pivotal role of aligning HCP needs, disease awareness, scientific data, patient identification programmes and marketing activities with your overall sales and account strategies.
You will engage with health care professionals, agencies in close collaboration with your cross functional team colleagues from medical, market access and nordic marketing to drive sales and prioritized activities based on your indepth market monitoring and understanding.
The major responsibilities of this role include both strategic and operational sales tasks, product promotion activities concerning disease awareness, planning and executing of projects supporting patient identification programmes as well as some selected traditional marketing activities aligned with the multi country strategic plan.
Hansen Toft A/S recruiting on behalf of Mundipharma Nordics
New organization with an intense growth strategy - based in Denmark or Sweden
You will report to the Managing Director for the Nordics and be responsible for a team of 3 skilled professionals. You will be overall responsible for developing Nordic regulatory strategies for established and new products to ensure successful market introductions/registrations. In details, you will:
- Ensure solid industry best practice within the Nordic Regulatory/PV/QA approach
- Provide timely strategic regulatory input and support the Nordic needs for development and regulatory plans for pipeline
- Drive the approach for the regulatory affairs and ensure regulatory compliance
- Oversee that relevant conditions at a Nordic level are in place to accommodate both internal European demands and authorities’ requirements for PV, Complaint handling and QA
Do you want to influence the future of global Healthcare Professional (HCP) customer engagement at Novo Nordisk?
Novo Nordisk, Søborg