Regulatory Affair Specialist

Are you looking for a new job opportunity where you can shape tomorrow's standards for diagnosing cancer and help optimizing cancer patients treatment? Do you like new challenges where you can make a real difference using cutting-edge technology and high ethical standards?

This includes but is not limited to:

• Developing and performing the regulatory strategy.
• Ensuring compliance with IVD legislation such as IVDR, 510k (FDA), UKCA, and GMP.

Clinical Research Associate (CRA)

Do you have a good eye for details, and are you known for being solution-oriented and seeing possibilities rather than problems?

NBCD A/S is an international niche Clinical Research Organization (CRO) specialized in clinical drug development of innovative medicines.

One of your tasks is to perform on-site monitoring of the trials performed by NBCD according to ICH-GCP. This involves visiting hospitals and clinics in Denmark and other countries.

Medical Director

Currently, we are looking for a new Medical Director who has a medical background, experience from conducting and designing pharmaceutical industry trials.

We are looking for a self-driven team-oriented colleague with the capability to lead cross-functional teams towards innovative solutions for delivering the highest standard clinical development trials for our drug candidates.

(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.

Senior Specialist, Regulatory Affairs Life Cycle Management

Dedicated RA specialist with strong quality focus and an eye for Life Cycle Management

In this role, you will in collaboration with the team be responsible for managing the regulatory aspects of our generic portfolio after receival of the marketing authorization, ensuring compliance with current legislation throughout the product lifecycle.

Key responsibilities:

• Handling module 3 variations
• Review and/or author CMC documentation

Senior Clinical Data Manager

Are you an experienced clinical data manager whom is ready for the next step in your career? Are you excited about taking on more responsibility for data management deliveries and a more oversight perspective to clinical trials?

Here you will be part of an environment driven by dedication and a positive mind-set, you will have the opportunity to make a difference and you will have the opportunity to broadening your skillset, being introduced to all clinical and non-clinical pre-market aspects of drug development in one place.

Regulatory Affairs Senior Specialist

Convatec Infusion Care is expanding and currently looking for a new colleague to join our Regulatory Affairs Department.

The primary responsibilities of the position are to ensure regulatory compliance of a defined group of Convatec products, drive regulatory processes and activities (such as regulatory strategy, product registration, change control, review of marketing materials, etc) and continue to develop strong working relationships with internal and external customers.

QA-assistent til international producent af kosttilskud og lægemidler

‎Trives du med at arbejde i et GMP-reguleret miljø, og vil du gerne bidrage til at opretholde den høje kvalitet?

Vi tilbyder et alsidigt job i et åbent og dynamisk arbejdsmiljø med muligheder for faglig og personlig udvikling.

Du kommer til at indgå som en del af et tæt tværfagligt samarbejde med bl.a. laboratorie-, kemi- og kvalitetssikringsafdelingen. Du vil være tilknyttet kvalitetssikringsafdelingen, hvor der vil være gode muligheder for udvikling.

Opgaverne kan bl.a. bestå i:

• Gennemgang, kontrol og frigivelse af råvarer, færdigvarer eller emballagedele.
• Arkivering af dokumentation og referenceprøver.
• Supportfunktion for øvrige afdelinger i form af certifikater og øvrig dokumentation.

Clinical & Product Training Manager (EMEA/Asia) to GE HealthCare Denmark

This is your opportunity to become part of an innovative team where your work has a real impact on people’s lives around the world.

Our global Clinical and Product training team consists of fifteen dedicated and passionate specialists with a mix of seniority, educational backgrounds, and nationalities.

We are a strong team that values collaboration, support, honesty, and respect. We are driven by making a difference and continually improving training activities across the globe.

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.

Farmaceuter til Regulatory Affairs

Vi mangler hurtigst muligt 2 Regulatory Managers med interesse for og meget gerne erfaring med Regulatory Affairs. Stillingen byder på et bredt udvalg af opgaver, og du vil også få mulighed for at arbejde med marketing compliance.

Du skal bl.a. lave compliance review af marketingaktiviteter og -materialer for den farmaceutiske industri og anmeldelser til Etisk Nævn for Lægemiddelindustrien samt oversættelser af regulatoriske og medicinske dokumenter (dansk/engelsk).