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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

Senior Specialist til QC hos Xellia Pharmaceuticals

Drømmer du om mere ansvar, med forskelligartede opgaver, og har du en passion for mikrobiologi? Vil du spille en central rolle i Xellias produktionen af livsvigtig antibiotika?

Som senior specialist vil du blive faglig ansvarlig for vores count release-laboratorie, som bl.a. udfører TVC- og LAL-analyser. Derudover vil du indgå i tæt samarbejde med vores sterile produktioner angående EM, hvor de nye Annex 1-krav stiller øgede krav til vores compliance, som du vil spille en vigtig rolle i.

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

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.

Analyst and Project Coordination In Life Science Consultancy

Would you like to work with data analysis and research of worldwide trends in the pharmaceutical and biotechnological industries?

You will get the responsibility of managing and coordinating the day-to-day operations needed to solve our projects and writing reports for our commercial unit.

An academic background in life science (pharmacy, biotechnology etc.), economics or similar is required.