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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

Professional, Visual Inspection

Kunne du tænke dig at være med i et spændende eventyr hos en fabrik i rivende udvikling? Har du erfaring med GMP i lægemiddelindustrien?

Du vil blive en del af Production Support og vil være tilknyttet visuel inspektionsprocessen, hvor du vil være med til at sikre proces, procedurer, GMP og generelle forbedringer på vores proces.

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.

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.

Dedikeret farmakoepidemiolog til Lægemiddelstyrelsens Dataanalysecenter

Lægemiddelstyrelsen er en helt unik arbejdsplads, i at vi er Danmarks eneste regulatoriske myndighed for lægemidler og medicinsk udstyr. Med denne position følger et helt særligt ansvar, som vi er meget stolte af og bevidste om i vores arbejde.

Dine primære arbejdsopgaver i Lægemiddelstyrelsens Dataanalysecenter er bl.a.:

• Designe, planlægge og udføre farmakoepidemiologiske analyser på sundhedsdata bl.a. vedr. forbrug, effekt og sikkerhed
• Udarbejdelse af rapporter, notater og præsentationer til forskellige målgrupper

ENVIRONMENTAL PROFESSIONAL (VIKARIAT)

Ønsker du en karriere i en vaccinevirksomhed som både udvikler, producerer og sælger vacciner til hele verden, så læs videre her.

Du vil blive involveret i den daglige drift, og vi vil sikre, at du får de rigtige kompetencer til at løse dine opgaver, så du nemt kan supportere vores vaccineproduktion med:

• Support til vores procesfolk i aseptisk produktion
• Dagligdagsudfordringer i produktionen

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

Craft Brewer

Er dit drømmejob at lave innovative øl af de bedste råvarer i et lille og dynamisk team, i tæt samarbejde med forskere? Og matcher du de fleste af nedenstående kvalifikationer?

Ansvarsområder

• Brygning, gæring, tørhumling, filtrering og rengøring på semiautomatiske anlæg
• Tapning på dåser og forskellige fustager på semiautomatiske anlæg

Utility Engineer

Er du klar til at blive en del af en innovativ, international vaccinevirksomhed, som den tekniske specialist?

I rollen vil dine primære arbejdsopgaver være support til teknikere og brugere, herunder hjælp til fejlsøgning på anlæg og udstyr, samt at sikre:

• Robusthed af anlæg ved kontinuerligt at have styr på vedligehold
• At GMP og regulatoriske krav er overholdt

Department Manager for Molecular Pharmacology

Gubra is seeking a dedicated and experienced Department Manager to lead our Molecular Pharmacology department. The ideal candidate will possess proven leadership abilities and a passion for managing and developing teams, along with a background in molecular pharmacology and drug discovery.

Your tasks include

• Daily management of a team of scientists and lab technicians to ensure high performance, personal development, well-being and engagement.
• Guide the team to accomplish department goals and objectives.
• Oversee the planning, execution, and analysis of experiments to support Gubra’s internal and partnered drug discovery projects.

QA Specialist og Senior QA Specialist

For dig, der trives med at arbejde med kvalitet og lovgivning fra et operationelt perspektiv, både selvstændigt og i dialog med vores leverandører og interne afdelinger.

Som QA Specialist vil du være det koordinerende bindeled mellem de forskellige teams i QA, regulatorisk og Pharmacovigilance i relation til udfærdigelse eller opdatering af eksisterende TA.

Quality Supporter

Har du øje for detaljen og fokus på kvalitet? Henter du samtidig energi via dialog og samarbejde? Så er du måske vores nye Quality Supporter.

Elopak Denmark A/S søger endnu et sæt kompetente hænder og et skarpt hoved til at supplere vores eksisterende laboratorieteam i kvalitetsafdelingen.

Vi tilbyder en attraktiv lønpakke med unik pensionsordning, sundhedsforsikring, personaleforening, tilskud til fitness, kantineordning, gode kollegaer, samt faglig og personlig udvikling igennem hele din karriere hos Elopak.

Product Portfolio Manager, Arla Foods Ingredients - Aarhus

Together with the rest of the team you will make raw material scenario analyses and identify potential challenges to have a fact-based discussion and enable better decision-making.

In short, your responsibilities and tasks include:

• Become a trusted portfolio partner to the commercial organization
• Provide raw material priority recommendation in S&OP and other key-forums

Project Coordinator

Do you have experience managing projects anchored to a GMP facility? Are you eager to contribute to the development of a newly established project team in a production environment?

As a Project Coordinator, you will participate in the successful planning and completion of projects related to the Drug Substance Manufacturing Processes. You will coordinate and follow up on a number of tracks that links to various projects.

Scientist for In Vivo Sales in Boston

Are you passionate about discussing science, identifying opportunities for customer value creation and creating visible results? Do you have excellent analytical skills and a strong commercial mindset? Are you a natural communicator and thrive building relationships? If that is the case, we have a great career opportunity for you.

Your primary area of responsibility will be to partake in day-to-day sales operation, drive the forward-looking dialogues with key customers as well as identifying and following up on new business opportunities. Furthermore, you will be involved preparing sales presentations, market analyses, and marketing materials.

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.

Senior QA / Systemansvarlig

Som systemansvarlig for kvalitetssystemet vil du have en bred funktion, hvor du vil blive involveret i alle aspekter i virksomhedens kvalitetsarbejde.

Arbejdsopgavernes karakter spænder fra det strategiske til det operationelle, og deres udførelse kræver en vekslen mellem at sidde ved skrivebordet og at være ude på gulvet.

Både de faglige og de personlige udviklingsmuligheder ligger lige for i en rolle, som skal varetages med både selvstændighed og løbende sparring med virksomhedens erfarne kvalitetschef.

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.

Projektleder med erfaring indenfor Pharmaindustrien

Vil du arbejde med spændende og varierende projekter inden for Pharma og Biotech og kunne du tænke dig at blive del af et dygtigt tværfagligt team, hvor humøret og ambitionerne er tårnhøje?

Helt konkret vil du arbejde med:

• ledelse af projekter med stor spredning i størrelsesorden fra 1-50 mio. DKK
• ledelse af tværfaglige projekter med leverancer indenfor Process, Mekanik, Automation, El, Instrumentering, Q, HSE samt Byg
• rådgivning- og konsulentopgaver