We are looking for a Trainee Regulatory Affairs at our site in Fribourg for the minimum duration of 6 months. In this role you will directly report to the Head of Regulatory Affairs Switzerland and support Regulatory Affairs Managers by acquiring knowledge and supporting in the following activities. Your tasks will include, but not be limited to, the following:
- Manage the documentation relating to regulatory files for medicinal products, in particular traceability and archiving in a dedicated electronic system
- Provide support to Regulatory Affairs Manager in the preparation of application dossiers and their submission to Health Authorities
- Provide support to Regulatory Affairs Manager in checking the conformity of packaging texts and cross-functional review of new texts before submission
- Provide support in preparing renewal of marketing authorisation and submission of PSURs
- Provide dedicated regulatory support to the internal teams for the product portfolio
You bring the following profile:
- Completed Master degree in the field of pharmacy or natural science
- Fluency in English and French language, orally and in written
- Good command of both written and spoken German language
- Good user abilities in the computer environment: Microsoft Office, Internet, databases, etc.
- Good teamplayer
- Accuracy, flexibility and ability to work under stress, following timelines and deadlines
- Self-assertion, creative, solution-oriented work approach
You have excellent communication and negotiation skills at all levels (for internal and external stakeholders), and discretion in the handling of confidential information. In your communication you are clear and accurate, both verbally and in writing. You have strong analytical skills and think and act strategically. You understand urgent needs, can set priorities accordingly and resolve issues appropriately and in a timely manner. You are customer oriented and take a proactive approach to identify service support. In this role you will work with diverse teams at all levels and functions, which is why your teamwork and communication skills will be important.
Vifor Pharma Group, formerly Galenica Group, is a global specialty pharmaceuticals company that researches, develops, produces and markets its own pharmaceutical products and is the partner of choice for innovative, patient-focused solutions. The companys goal is to be a global leader in iron deficiency, nephrology and cardio-renal therapies and strives to help patients around the world with severe and chronic diseases to lead better, healthier lives.
Vifor Pharma Group has production sites in Switzerland and Portugal as well as a dynamic network of affiliates and partners offering broad market coverage all over the world.
The company has an ever-growing global presence while at the same time remaining firmly rooted in its home market, Switzerland.
Vifor Pharma Group consists of Vifor Pharma; Vifor Fresenius Medical Care Renal Pharma, its joint company with Fresenius Medical Care; Relypsa; and OM Pharma.
For more information, please visit: http://www.viforpharma.com/en/about-vifor-pharma/who-we-are