15 job matcher din søgning
Are you dedicated to communication of complex scientific matters in a written form? Do you have experience with global regulatory CMC (Chemistry, Manufacturing and Controls) requirements for biological products and Regulatory Life Cycle Management of medicinal products globally? Do you enjoy cross-functional interactions?
Field of responsibility
- Writing and maintaining regulatory CMC documentation for initial and life cycle submissions
- Having an overview of submitted and approved CMC documentation in different regions
- Cross-functional and external cooperation related to product development and/or strategic expansion
We offer an exciting and challenging job with your own areas of responsibilities.
Vivostat A/S, Allerød
As QA manager you will be responsible for the company’s electronic Quality Management System. An important part of your role is to promote the awareness of quality, regulatory, customer and statutory requirements throughout the organization and to head projects in our constant strive to improve quality in all aspects.
As RA Manager you will be responsible for maintaining EU and other international regulatory filings and for ensuring a smooth transition to MDR.
Working hours is anticipated to be 25-30 hours/week with flexible working days.
Duties and responsibilities
- Maintain and update quality system policies and procedures
- Interpret and implement quality assurance standards and procedures
- Maintain and update technical files
PharmaLex Denmark A/S, Hørsholm
We are looking for motivated, committed candidates who will enjoy working independently within our successful team in a challenging environment. So, if your career is much more than just a job for you but rather your passion, then come and join our successful team. In Denmark we are looking for a Senior Pharmacovigilance Specialist with a strong pharma background.
As a part of our Pharmacovigilance team, your re-sponsibilities will include, but not be limited to, the following:
- Participate in pre- and post-market drug safety projects in a global organization.
- Management of adverse drug reactions.
- Production and review of periodic safety re-ports and risk management plans.
We offer you exciting and varied challenges in a friendly team, as well as many opportunities for personal development and job training.
Y-mAbs Therapeutics A/S, Hørsholm
A new position is now open in our CMC development team.
Y-mAbs Therapeutics A/S (Y-mAbs) is looking for a CMC Project Manager who can contribute to our efforts in bringing our pipeline of exiting products through the clinical development phase and into commercial supply. You will work on all CMC activities associated with our development programs, and have a close collaboration with other functional groups within Y-mAbs.
- You will manage, coordinate and drive the Chemistry, Manufacturing and Control (CMC) part of projects in early and late stage development and towards commercial launch
- Coordinate activities within drug development and quality control using external vendors
- Be responsible for writing and reviewing the technical content of the regulatory documents for IND’s, IMPD’s and other regulatory submissions
The Danish Diabetes Academy (DDA) invites applications for:
- 6 co-financed (2/3) PhD scholarships
- 2 two-year and 3 three-year postdoctoral fellowships
- A number of visiting professorships/assistant professorships
The applications should be within diabetes and metabolism. Applications supporting the three major strategic areas of the DDA: Internationalization, interdiscipliniarity and collaboration across sectors will be prioritized.
Gubra ApS, Hørsholm
Gubra is growing rapidly and is therefore looking to hire a new animal technician to join our In vivo pharmacology team.
You will work in close collaboration with Scientists, Laboratory Technicians and of course the other animal technicians in the planning and executing our long list of research projects. Therefore, it is essential that you enjoy communicating with many different people during a workday.
- Care of experimental animals – mainly mice and rats
- Executing animal experiments and collecting data
- Working with animal models for obesity and diabetes
- Manual blood samplings during an experiment and/or at terminations
FirstVet is growing in Denmark and we want to get in touch with dedicated veterinarians who are passionate about helping people and animals, and at the same time are ready to try a new, video call based way of working. We offer varied work with great flexibility, both in terms of working hours and location.
Pet care is changing and digitisation is becoming increasingly important. FirstVet's vision is to streamline the interaction between pet owners and veterinarians by offering advice and simple initial screening examinations through video meetings on mobile telephones, computers and tablets. An initial video call offers many advantages, including the ability to initially assess the animal in its safe, home environment. The veterinarian can quickly assess the pet’s condition, and through communication with the owner, either recommend simple treatments or provide referral to a local veterinary clinic.
Bavarian Nordic A/S, Kvistgård
As Senior Director of Regulatory Affairs, you will get a unique opportunity to impact Bavarian Nordic’s future success by ensuring global CMC regulatory strategies, driving CMC activities and meetings with partners and international health authorities, as well as secure the successful commercialisation of several promising vaccines.
You will be responsible for developing the global CMC regulatory strategy for current and future oncology and Infectious Diseases programmes, ensuring that regulatory documents are in compliance with health authority regulations and interact with international health authorities. Reporting to the Senior Vice President Quality, you will have regulatory accountability across all Bavarian Nordic’s vaccine development programmes and contribute actively in building regulatory capabilities.
Medican A/S, Helsinge
As a Medican Quality Assurance Pharmacist, you will be ensuring that Medical Cannabis Products comply with the local and international quality assurance standards, safeguarding legal compliance to these and thereby ensuring the quality assurance function in totality.
- Ensure adherence to the medican quality system and Danish/ international requirements when executing quality activities
- Act as QP deputy/delegate for release of commercial product batches to the designated market timeously and in line with requirements
- Participate in SOP writing/reviews
If we stated that you now had a chance to work to significantly change people's hearing experience worldwide by utilizing your skills within regulatory processes. Would you then dare to take it?
Our RA department consists of 16 highly dedicated people and is part of the QA & RA department. As a department we are responsible for the regulatory strategies for R&D project throughout the product development process.
You primary and secondary tasks would be to:
- Take lead on updating the product Medical Device Files to be in compliance with the new EU Medical Device Regulation.
- Take lead on regulatory aspects in R&D projects
- Provide Regulatory Affairs Project Support, which includes managing and documenting the regulatory project strategy, classification and intended use, risk management file, standard requirements, technical file and review of marketing material.
Bavarian Nordic A/S, Kvistgård
Would you like to fight Ebola and other life-threatening diseases? At Bavarian Nordic you can take responsibility of your own step of evolution in our development process.
Stepping into Production Support, you will join +25 academics in charge of introducing new products to our production, taking care of any occurrences that happen during production and handling all documentation afterwards.
As our new Process Specialist, you divide your time between:
- Documenting our completed productions
- Handling deviations
- Writing SOPs
Compass Human Resources Group A/S recruiting on behalf of client
Are you passionate about healthcare products and up to the challenge of creating a name for yourself in the surgical equipment marketspace, then here is the opportunity for you!
As Sales Product Specialist, you will help delivering on the company’s mission of making healthcare better by promoting and selling world-class surgical products. With your strong documented ability to acquire and develop new customers, you are a vital part of the process from the initial contact to the after sales support. Your customers know they can count on you as a qualified and dedicated professional.
Your tasks include:
- Identification and contact to new potential customers
- Planning and executing quarterly and annual business plans
- Negotiating pricing and managing contracts and terms of transactions within your territory