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Regulatory Affairs Specialist

We are on an exciting path of growth and are currently seeking a new specialist to join our team and play a crucial role in ensuring that our operations adhere to relevant regulations and industry standards.

A significant part of your role will be to take regulatory ownership of selected product areas, and ensure the required activities take place, to ensure we are following current regulatory standards for medical device development.

Regulatory Compliance Specialist

Do you want to influence regulatory compliance and future medical product development in a global company that provides an attractive workplace for the industry’s best and brightest?

You will play an important role in ensuring that our products meet all regulatory requirements while upholding our commitment to quality and innovation.

A significant part of your role will be to take part in planning and implementing the required documentation, including usability engineering and risk management, in compliance with current regulatory standards for medical device development.

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.

Quality & Compliance Manager

Are you passionate about quality and decency, and do you want to hold a key position in a growing sound international company focused on sustainability? Then you should read on.

You will be a part of the global supply chain organization in Middelfart and report to COO. The area of responsibility is material quality, compliance, and risk management, and you will be the driver of creating a culture of continual improvement by identifying opportunities for efficiency and innovation within the quality and compliance area with a focus on sustainability and the global ESG agenda.

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.

Head of Business Process Optimization

Do you excel at improving business processes and leading employees in the right strategic direction?

As Head of Business Process Optimization, you will be responsible for building and maintaining our capability to develop, implement, and continuously improve business processes.

Project Manager, Specialty Rx & OTC

Would you like to become part of a dynamic, international and ambitious environment?

Key responsibilities includes:

• Building, maintaining, and optimizing the project plan throughout the project life time
• Monitoring project progress as well as ensuring tasks and deliverables are completed within the agreed upon deadlines

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.