Calliditas Therapeutics is a specialty pharmaceutical company based in Stockholm, Sweden focused on identifying, developing and commercializing novel treatments in orphan indications, with an initial focus on renal and hepatic diseases with significant unmet medical needs. Calliditas’ lead product, TarpeyoTM, is a proprietary, novel oral formulation of budesonide, an established, highly potent local immunosuppressant, for the treatment of the autoimmune renal disease IgA nephropathy, or IgAN, for which there is a high unmet medical need and there are no approved treatments. As of December 15th 2021, the FDA has approved the commercialization of Nefecon (TARPEYOTM) in the United States thus making it the first and only FDA-approved treatment. Calliditas is listed on Nasdaq Stockholm (ticker: CALTX) and the Nasdaq Global Select Market (ticker: CALT). Visit www.calliditas.com for further information.
Join us as our new Regulatory and Quality Assistant and become part of an exciting environment. Our colleagues in Regulatory and Quality have a unique combination of scientific insight, patient focus, and the ability to navigate many agendas and different internal and external stakeholders. That makes these two areas a truly interesting and challenging place to work.
As Regulatory and Quality Assistant you will be supporting both the Regulatory Affairs (RA) and the Quality Assurance (QA) functions. You will report to the Head of Regulatory Affairs, but in the daily work you will be a part of both areas.
Key tasks and responsibilities
- Aid and support the regulatory submissions and quality documents from the preparation phase, through completion to archiving.
- Aid and support amongst other registration, documentation, corrective/preventive actions related to products, processes, projects, suppliers, and partners.
- Coordinate registration and reporting of monitoring and follow-ups related to regulatory and quality business processes.
- Provide administration and support to users of the clients’ document management systems, Veeva Quality Docs and Veeva RIM.
- Coordinate, perform and follow up periodic audits owned by the departments of Quality Assurance and Regulatory Affairs and completion of documentation of the activities related to the customer's quality management system, products, internal and external audits, suppliers and partners.
Education and experience requirements
We’re looking for you who have at least a completed high school degree. It is highly meritorious if you have previously worked in a similar position and industry or an industry similar to medical equipment. Furthermore, you should have experience in computerized systems for information handling and documentation, good knowledge of Microsoft Office, excel for example, and be fluent in English and be comfortable both in speaking and writing in English. As a person, you must be thorough, flexible and driven. You must also be pedagogical and have a great ability in prioritizing your work. You must also enjoy a working environment where a lot is going on and where you need to juggle many things at once.
Reasons to join the Calliditas Team
- Be a part of a global leader in IgA- Nephropathy and a rapidly growing commercial-stage pharmaceutical company
- Be a part of the commercialization of TARPEYOTM and our focus to file for approval with EMA
- Get in on bonus and benefit programs
- Fast paced small company environment
Are you the person we’re describing above? Then take this chance and apply for the position immediately!
Welcome to join the Calliditas Team!