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Postdoc in Biotechnology – DTU Chemical Engineering

Department of Chemical and Biochemical Engineering invites applications for a position as Post Doctoral Fellow to be hired within the frame of a project on biogas conversion to single cell protein in the form of methylotrophic bacteria, where optimising synergistic microbial interactions is a key element.

Project focus is on recovery of nutrients from the biogas digestate by microbial or electrochemical methods.

2 Regulatory and Marketing Compliance Managers

Har du interesse for og meget gerne erfaring med Regulatory Affairs – og helt optimalt med Marketing Compliance – og vil du gerne arbejde mere målrettet med Marketing Compliance?

Dine arbejdsopgaver bliver bl.a.:

• Compliance review af marketingaktiviteter og -materialer for den farmaceutiske industri og anmeldelser til Etisk Nævn for Lægemiddelindustrien
• Oversættelser af regulatoriske og medicinske dokumenter (dansk/engelsk)
• Andre regulatoriske opgaver svarende til opgaverne i et dansk datterselskab: gennemgang og opdatering af produktinformation, regulatorisk review af artwork m.v.

Produkt- og reguleringsansvarlig / PSRA-officer

Er du klar til at påtage dig en vigtig rolle i udvikling og implementering af den regulatoriske strategi for Bostik og LIP Nordic, der er førende producent af byggematerialer i Norden?

Vi stræber efter at skabe en innovativ og fremsynet arbejdsplads hvor dine idéer kan blive til virkelighed.

Som PSRA Officer er du i frontlinjen af den regulatoriske strategi. Ansvarsområderne inkluderer at produkterne sikrer fuld overholdelse af både dansk- og EU-lovgivning samt overholdelse af krav om miljø og andre regulatoriske regler og sikre at dokumentation har compliance til de højeste standarder.

PhD scholarship in Microalgae for fish feeds - DTU Aqua

If you are interested in establishing a career within aquaculture & nutrition and work on microalgae as feeds for aquaculture in a context of solutions to improve sustainability and circular economy, this three-year PhD Scholarship should be something for you.

DTU Aqua offers a 3-year PhD position in microalgae for fish feed. Your overall focus will be on different microalgae species and their nutritional quality for use in aquaculture feeds.

Erfaren QA-Specialist – til frigivelse af produkter

Stillingen byder på et bredt udsnit af QA-opgaver og flere kan komme til, så du får gode muligheder for at videreudvikle dine QA-kompetencer.

Opgaverne:

• Selvstændig frigivelse af PKC’s produkter og behandling af afvigelser og håndtering af ændringssager
• Sparringspartner for QA-gruppen, QC-gruppen og produktionen

Du får ansvar for og stor medbestemmelse over dine opgaver. Der er tid til fordybelse, men der er også dage, hvor det går rigtig stærkt, og opgaverne blev andre end dem, du havde planlagt og forventet.

(Senior) Drug Substance Specialist

We are currently seeking a (Senior) Drug Substance Specialist who is energized by collaborative and fun teamwork, excels in handling complex tasks, and enjoys continuous learning.

Your responsibilities will include late-stage drug substance development, up-scaling and process validation as well as support in the commercial phase. Effective coordination with external partners is a significant aspect of this role.

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.

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

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.

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.

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