Regulatory affairs associate with a scientific profile
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København N
Do you have a compliance mindset and a keen interest in regulatory affairs? Do you enjoy collaborating with internal and external partners to ensure that services are delivered on time and in compliance with relevant guidelines? Then you might be our new colleague!
RefLab is a small Danish biotech company with a service laboratory founded on our extensive expertise in allergy/chronic spontaneous urticaria diagnostics and servicing hospitals and allergy/immunology specialists worldwide. Furthermore, we have a contract research unit providing preclinical services for the pharmaceutical industry with a proven 10+ year track record and a solid pipeline.
As we are becoming increasingly engaged in large projects involving analysis of clinical samples, we are in the process of becoming fully GCLP compliant and looking for a candidate who can support us on this journey. Our diagnostic tests are ISO 17025-accredited, and we produce our own kits under ISO 13485 regulations, so the ideal candidate will be familiar with the regulatory framework related to these ISO standards and GCLP (alternatively GMP/GDP/GLP) and have a good scientific background to act as a bridge between our QA Manager and contract research scientist. As part of this permanent position, which may be full time or part time depending on qualifications and the candidates’ wishes, you will be involved in planning and execution of our contract research projects and play an important role in the company.
Your tasks will include (but are not limited to):
Qualifications:
Application
Please send us your application before the 12th of July 2021. Interviews will be conducted continuously, so please do not hesitate to send your CV + motivational letter to [email protected] and always feel welcome to contact our Senior Scientist, Katrine Baumann ([email protected]; +45 70702345) or QA Manager, Lise Bo (+45 70702345) for further details. We expect the candidate to start as soon as possible and preferably no later than 1st of August 2021.
Kilde: Jobnet.dk
RefLab is a small Danish biotech company with a service laboratory founded on our extensive expertise in allergy/chronic spontaneous urticaria diagnostics and servicing hospitals and allergy/immunology specialists worldwide. Furthermore, we have a contract research unit providing preclinical services for the pharmaceutical industry with a proven 10+ year track record and a solid pipeline.
As we are becoming increasingly engaged in large projects involving analysis of clinical samples, we are in the process of becoming fully GCLP compliant and looking for a candidate who can support us on this journey. Our diagnostic tests are ISO 17025-accredited, and we produce our own kits under ISO 13485 regulations, so the ideal candidate will be familiar with the regulatory framework related to these ISO standards and GCLP (alternatively GMP/GDP/GLP) and have a good scientific background to act as a bridge between our QA Manager and contract research scientist. As part of this permanent position, which may be full time or part time depending on qualifications and the candidates’ wishes, you will be involved in planning and execution of our contract research projects and play an important role in the company.
Your tasks will include (but are not limited to):
- Maintaining up-to-date knowledge and understanding of relevant regulatory requirements
- Overseeing the regulatory aspects of contract research projects and supporting the scientific project manager
- Identifying and reporting any quality or compliance concerns and take immediate corrective action as required
- Taking part in various daily operational tasks in a dynamic and challenging environment
- Providing regulatory support during negotiation of service agreements with clients
- Supporting internal and external audits, by ensuring compliance to regulatory requirements and applications as well as providing regulatory guidance
- Providing critical review of existing documentation and drafting relevant documentation upon request of our customers
- Driving collaboration across departments to remediate top compliance risks and engage in cross-functional planning
Qualifications:
- The ideal candidate holds a degree in life science or pharmaceutics and has several years of experience in regulatory affairs
- Previous CRO experience or involvement in clinical trials is a strong asset
- Ability to work simultaneously on different projects and deliver on time
- Self-motivated, responsible, well-organized and a strong team player
- Excellent verbal and written communication and presentation skills with the ability to speak and write clearly and in English and Danish
Application
Please send us your application before the 12th of July 2021. Interviews will be conducted continuously, so please do not hesitate to send your CV + motivational letter to [email protected] and always feel welcome to contact our Senior Scientist, Katrine Baumann ([email protected]; +45 70702345) or QA Manager, Lise Bo (+45 70702345) for further details. We expect the candidate to start as soon as possible and preferably no later than 1st of August 2021.
Kilde: Jobnet.dk
Information og data
Denne ledige stilling har jobtypen "Produktspecialist", og befinder sig i kategorien "Kommunikation, marketing, salg".
Arbejdsstedet er beliggende i København N.
Jobbet er oprettet på vores service den 29.6.2021, men kan have været deaktiveret og genaktiveret igen.
Dagligt opdateret: Dette job opdateres dagligt ud fra jobudbyderens hjemmeside via vores søgemaskineteknologi og er aktivt lige nu.
- Produktspecialist
- København N
- Mandag den 12. juli 2021
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