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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.

Product Sustainability Specialist

Vi søger en kollega, der sammen med afdelingens øvrige specialister kan sikre, at Flüggers produkter er i overensstemmelse med lovgivningen, samt opfylder kravene til de forskellige frivillige ordninger indenfor bæredygtighed.

Du vil få en spændende og afvekslende hverdag, hvor du vil være ansvarlig for planlægning og udførelse af egne opgaver. Opgaverne er mangeartede og der er stor mulighed for personlig udvikling.

Sales Manager

Are you seeking to make a difference in an innovative, fast growing medtech company with a cutting-edge technology? We're currently seeking a dedicated individual to fill a position as Sales Manager.

Your main responsibilities

• Lead generation
• Develop and execute sales strategies
• Customer relationship management

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

Scientist (maternity leave temp), cell-based immunotherapies

Are you enthusiastic about developing next generation cell-based immunotherapies that bring new hope to late-stage cancer patients?

You will help the R&D team in a 6-months temporary position as one of our coworkers is on maternity leave, and will help the team with a possibility for further extension.

We are looking for a person experienced in immune oncology or related area with documented practical experience in cell culture and flow cytometry.

Sales Trader

We are looking for a Sales Trader who will play a vital role in ensuring BioCirc’s ambitious growth plans.

The successful candidate will together with the Portfolio Manager be responsible for the short-term sale of Certificates, optimizing the portfolio, gather market intelligence, and ensuring value added through the whole supply chain of biomethane production, but also new renewable products stemming from our energy clusters.

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.

QEHS Manager

Unique opportunity to join an innovative biotech company with a proven and sustainable technology on the edge of global expansion.

Do you want to help develop the protein of the future, which will make it possible to feed the world's growing population without damaging our ecosystems?

You will be leading a small team responsible for managing and coordinating all QEHS activities, including certifications, audits, and training. You will ensure that operations are conducted in a safe and efficient manner and in conformance with safety regulations.

Senior Test Engineer

Join GE HealthCare to help perform transducer integration on our next-generation ultrasound scanners and further develop our test tools and laboratories.

As our new Senior Test Engineer, your typical tasks will include measurements of sound pressure, acoustic power, thermal characteristics, image performance and other transducer properties.

You will take part in hands-on work while also playing a key role in maintaining and further developing our transducer integration processes and two laboratories.

Regulatory Affairs Manager

The Regulatory Affairs Manager at Radiometer is responsible for managing the preparation and submission of the required documentation for product registration, approval, and compliance with international regulations.

This role is critical for ensuring that Radiometer's products can be sold in markets around the world. You will have the opportunity to:

• Ensure regulatory compliance to maintain market approvals
• Lead a team of skilled RA associates
• Ensure alignment with relevant stakeholders

HSE Specialist

As an HSE Specialist, you will have the opportunity to develop and implement safety policies and procedures, conduct training sessions, and ensure compliance with local, state, and federal regulations.

In joining our team, you'll have the opportunity to make a significant impact, ensuring the safety and well-being of our workforce while contributing to our continued success at Duferco Danish Steel.

Senior Specialist Clinical Safety and Pharmacovigilance (CSPV)

At Bavarian Nordic, we aspire to save and improve lives by developing innovative vaccines that are designed to unlock the power of the immune system.

The global team consists of subject matter experts for vaccine safety who work either from our site or remotely in Denmark and globally. Together they constantly collect and assess data for the life cycle benefit risk management across our vaccines whether authorized or still in clinical development.

You would add your clinical safety and pharmacovigilance expertise as your depth knowledge of the PV legislation to the team.

Principal DMPK Scientist

Currently, we are looking for a new principal DMPK scientist, who has experience in supporting discovery and development projects in characterization and selection of drug candidates.

Responsibilities

• Design, conduct, and manage in vitro, and in vivo experiments to evaluate the ADME and PK profiles as well as toxicokinetics of drug candidates both in-house and at contract research organizations
• Develop and execute assays for measuring drug concentration and metabolite identification from in vitro and in vivo experiments

Senior QA Specialist

The Senior QA Specialist for Radiometer is responsible for ensuring safe, reliable, and compliant products during new product development and maintenance of existing product platforms. This is done by cooperating, supporting, facilitating, training, and communicating towards the best results with partners in R&D.

This position is part of the QA Design Control department, hybrid based and located in Brønshøj. At Radiometer, our vision is to improve global healthcare with reliable, fast, and easy patient diagnoses.

QA Specialist

You will be responsible for ensuring safe, reliable, and compliant products during new product development and maintenance of existing product platforms.

You will have the opportunity to:

• Provide Design Control guidance for QMS and regulatory compliance in an FDA regulated and ISO compliant environment.
• Represent Quality Assurance in design and development projects and in cross-functional teams supporting new product development.

Engineering Project Manager

Har du en passion for at drive teknologisk udvikling og bruge dine kompetencer i den grønne industrielle omstilling?

Den succesfulde kandidat vil have en ledende rolle i ALGIECEL's full-scale demonstrationsprojekt, der transformerer CO2-emissionerne på Novonesis' faciliteter i Kalundborg til bæredygtige algebaserede produkter gennem en yderst effektiv og kompakt fotobioreaktor.

Tiden for forandring er nu, og dette er din chance for at blive en del af vores højt motiverede team!

Senior Technical Writer - Regulatory (CMC)

You will join the Technical Writing team within Global Regulatory Affairs. We are responsible for global regulatory CMC writing of regulatory documents in applications for new approvals, worldwide market expansions, and product lifecycle activities. We work with a variety of pharmaceutical products, including small molecules, peptides, biologicals, recombinant products, and gene therapy.

Stepping into an informal and collaborative environment, you will have close interfaces with many different disciplines, including Global Pharmaceutical R&D, manufacturing sites, Product Supply, Quality Assurance, Ferring affiliates, and development sites around the world.

Manager, Chemical Substance Registration

The Manager, Chemical Substance Registration is accountable for implementing and executing the chemical control compliance programs of IFF in the EAME region (UK, EU REACH, Turkey REACH, EAEU etc.) for the technical enzymes’ portfolio of products (Biofuels, Fabric & Household Care, Textile Processing and Designed Enzymatic Polysaccharides).

The Manager, Chemical Substance Registration is furthermore a key contact for the Enzyme Business in determining strategic business decisions and should be representing IFF in industry work groups to assure IFF’s regulatory interests.