To create the best requisite for better healthcare, through working with the registration of medicaments. By evaluating processes and requirements and making sure they comply with company protocols and state regulations, you’re essentially ensuring patients are protected from harm.
Be instrumental in securing the needed supply for public hospitals by making sure all regulations and compliance are met for each medicament.
More specifically, you will:
- Assess regulatory implications, including specifying regulatory requirements and reviewing documentation
- Prepare and submit variation applications to the Danish Medicines Agency, and general dialog regarding potential product defects and recalls
- Lead conversations with the hospital pharmacies and other partners – both internally and externally
- Evaluate product quality review reports prepared by the hospital pharmacies
- Help establish clear, documented protocols
A team of experienced individuals who share knowledge and collaborate on fostering more health within the budget. The environment is open and casual, with you and your team claiming responsibility for the complete process – from the need for modifications to approval at the Danish Medicines Agency.
- MSc in Pharmaceutical Sciences or a degree in something similar
- A few years of regulatory experience in a similar job. Preferably within CMC and/or labeling
- In-depth knowledge of medicaments and regulatory demands.
- A detail-oriented and organized approach to your work
- A collaborative and kind persona
If you want to hear more about this opportunity and the company, or if you have any questions regarding the position, please do not hesitate to contact us. If you wish to apply for the position, please send an updated version of your CV, together with what questions you might have, and we will get in touch with you soon.