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Regulatory Affairs Clinical Specialist

Due to many activities in our exciting clinical development projects, we are seeking two new colleagues to our Regulatory Affairs function.

Your key responsibilities will be to contribute with regulatory expertise to global strategies and execution within your assigned project(s). You will be the regulatory responsible in the clinical trial teams and provide regulatory guidance and support for the planning, execution, and reporting of clinical trials worldwide.

Business Developer with a background in Science

Do you want to be at the forefront of Targeted Radiopharmaceuticals and Molecular Imaging?

We are looking for a professional Business Developer with a background in life sciences and the ambition to contribute to further strengthening Minerva Imaging as the trusted partner for targeted radiopharmaceuticals and molecular imaging.

What truly matters is your passion for the advancement and know-how of our scientific studies and your ability to foster long-term relationships with our collaborators.

Test & Reliability Engineer - Sustaining Engineering, Medical Devices

Do you have a keen eye for Physical Testing, Product Quality, Reliability, Validation, and Documentation? Are you looking for an opportunity to merge your passion with our expertise in the Test and Verification of Infusion Care Medical Devices, for the treatment of chronic diseases such as Diabetes and Parkinson’s Disease?

As a Test Engineer, you will be involved in developing and working with a diversity of physical test methods. Planning and coordinating tests in our laboratory in Osted near Roskilde, and partners within Global Convatec and external. Most of your time, you will be part of a project team in SEG.

Manufacturing Associate - Operator

We are looking for process operators, preferably with experience from a similar pharmaceutical production company or similar regulated businesses OR a Life Sciences Graduate who have recently finalized their Bachelor or Master degree relevant for Biologics Manufacturing and are keen on starting their career in a manufacturing and international environment where things move fast.

We are hiring for attitude, so we are looking for people who have a lot of drive and proven interest with working under GMP and enjoy working with numbers, math and IT tools.

Clinical Trial Assistant

Are you looking for the possibility to unfold your competences within clinical operations even further? Do you thrive in an innovative environment working alongside dedicated clinical research professionals? Are you a self-driven team player, who enjoys a varied and influential day at work?

Pharmacosmos A/S is a progressive and innovative pharmaceutical company with headquarters in Holbæk, Denmark. We are on an exciting journey of global growth inventing new and innovative treatments, and right now we are expanding our team with a Clinical Trial Assistant.

SAP Master Data Specialist

Do you want to be a part of Process Support in a company with a unique impact on global healthcare?

You will be coordinating SAP production master data activities throughout the organization in order to achieve safe and predictable product implementation, maintenance, and decommissioning.

Here you will not only get to impact the production and development of our products; you will also have every opportunity to develop and grow your own skills.

Senior Vice President, Global Chief Medical Office

We are seeking a highly experienced and dynamic medical executive to join our Global Research & Development organisation in a newly established senior leadership role as SVP, Global Chief Medical Office (GCMO).

In this role, you will act as scientific advisor to the EVP of R&D and the Global R&D leadership team, and your primary objective will be to ensure “one global medical voice” for ALK internally and represent the medical voice of ALK externally.

Manager Virus Production

Do you want to play a central and important role in Bavarian Nordic´s manufacturing strategy by setting directions and ensuring smooth daily operation in our production facility?

Our newly established Drug Substance Facility in Kvistgaard will soon start production ramp-up, and we therefore need to strengthen our leadership. You will become responsible for the day-to-day shopfloor management of 15-20 operators.

Specialist, Regulatory Affairs (Temporary Position)

As Regulatory Affairs Specialist, you will be responsible for lifecycle management of products manufactured at Orifarm’s own manufacturing sites. Therefore, you will collaborate closely with colleagues across functions, such as chemists, formulation specialists and co-workers within Quality, Supply Chain, Manufacturing and Sales.

Further, your main responsibilities include to:

• Gather information and documentation for variation applications
• Update dossier sections

Application Specialist – Beverages

Are you passionate about product development within all types of beverages from premium organic CSD's to flavored spirits?

You will work in a high-paced, collaborative and energetic environment optimizing key elements of beverage applications such as taste, stability, preservation and appearance with the goal to design the perfect balance between these elements.

Biocompatibility Specialist

We are looking for a Biocompatibility Specialist to join the Reprocessing and Biocompatibility team for a 12-month project position.

This is a great opportunity if you would like to gain experience with biocompatibility for advanced reusable medical devices, as you will be part of a cross-functional effort on documenting the safety and performance through the lifetime of our ultrasound scanners, transducers, and accessories.

QA Specialist

We are seeking a competent new colleague to join our QA team in a dynamic and growing company.

You will be part of our highly dedicated team consisting of 5 colleagues working with a broad range of QA tasks such as batch review, processing of complaints, deviations and change requests as well as validation and ad hoc projects.

Senior Medical Writer

Do you want to work in a global context and according to the highest standards of current practice to provide new products to patients with unmet medical needs?

As a Senior Medical Writer, you will be responsible for delivering submission-ready documents and take the role as lead medical writer on specific assignments. In addition, you can look forward to joining a diverse organisation shaped by cross-functional and global collaboration – and a focus on continuous transformation to support the future needs of clinical development.

Creative Assistant

Are you inspired to contribute your expertise to a global leading Flavors Organization? Are you passionate in working in a dynamic team with creative and empowered people?

Your Focus will be:

• Always following correct compounding procedures
• Prepare compounded flavors for evaluation, including preparation and running of difference testing if project requires.
• Coordinate with QC to obtain specifications of all experimental recipes within 24 hours of completion of evaluation.

Training Partner

Are you passionate about designing high impact training to improve ways of working?

The role will focus on re-designing the training related to onboarding our professionals working directly with our operation, our Operators, and our Laboratory Technicians.

You will meet a DK rooted company growing in number of international colleagues and a way of working, where hybrid, digital, learning and innovation are key words.

Associate Sensory scientist/Sensory Panel Lead - Arla Innovation Centre, Aarhus

We are looking for two new Sensory Panel Leads. One new collegue for a 1 year maternity cover and one for a 3 year project. For both positions we hope we will be able to prolong the employment or offer new challenges within Arla Foods.

Your key responsibilities will be:

• In close contact with stakeholders, guide and choose the proper test-setup to deliver the sensory results needed
• Panel training and development of panel competences within specific areas of interest

GMP-Supporter - Danmark Protein, Videbaek

Som GMP-supporter med fokus på forbedringskultur, leder du konstant efter måder at gøre vores produktionsmiljø bedre på. Dette gælder for sikkerhed og kvalitet.

Dine opgaver vil svinge mellem at være driftsorienterede, såsom GMP-runderinger til forbedringsaktiviteter og være projektorienterede, hvor du selv driver forbedringsprojekter, støtter og udfordrer vores teams og medarbejdere på deres rejse mod en forbedringskultur.

Technical Specialist, Product Quality, Nourish (Maternity cover, 12 months)

Are you an enthusiastic, motivated and detail-oriented professional with a desire to work in a team of colleagues with great technical competencies within production, regulation and processes?

Your core responsibilities:

• Handling deviations for products manufactured at our factories.
• Handling of product quality related complaints.
• Coordinate and implement customer-specific requirements. Maintenance of master data in various IT systems, including SAP.

Regulatory Affairs Specialist

The RA Specialist for Radiometer is responsible for ensuring coordination of regulatory activities for a few of our Blood Gas products manufactured in California to help ensure continued compliance in all markets.

In this role, you will have the opportunity to:

• Facilitate coordination of regulatory activities between California and Denmark for design control activities and international registrations for a few of the instruments/consumables manufactured in our California site.
• Ensure compliance with EU regulations.
• Generate STED files, international submissions & assess design changes.
• Plan and execute projects for new regulatory requirements.

Senior Regulatory Specialist

The Senior Regulatory Affairs Specialist at Radiometer is responsible for collecting and generating documentation for product submissions to ensure compliance with international regulations. This role is critical for ensuring that Radiometer's products can be sold in markets around the world.

If you thrive in a fast-paced environment, are used to playing a critical supporting role and want to work in a world-class efficient team that is part of a Global RA department and have interactions and stakeholders to connect with in a global scale - read on.