This job is currently Archived,
Posted on : 23 May 2017
The Regulatory Affairs Intern will provide support to the Department on several projects in Regulatory Affairs, and will have the opportunity to receive training from experienced team members.
- Support Regulatory Affairs department
- Archiving related documentations with the department
- Provide support to the regulatory team regarding regulatory intelligence activities
- As a result of the internship the individual should understand the specificities of regulatory activities in the Rare Disease area, the key clinical development strategies and regulatory aspects in orphan products, as well as gain understanding of some life cycle management regulatory activities.
- Responsible for reporting all pharmacovigilance events, product quality complaints and medical information requests within 24 hours as of awareness according to the local applicable procedures.
- Student in of Pharmaceutical studies or Master s Degree in Regulatory Affairs
- Computer literacy including MS Office software
- Able to handle multiple and changing priorities
- Rigorous, organized
- Flexibility and ability to adapt to changing conditions
- Sense of ethics and responsibility
- Pharmaceutical degree and/or Masters in Regulatory Affairs, or related scientific qualification
- Internship must be mandatory and social security has to be done by University
- Our company is a global biopharmaceutical company focused on developing and delivering life-transforming therapies for patients with devastating and rare disorders. Our company developed and commercializes the first and only approved complement inhibitor to treat patients with paroxysmal nocturnal hemoglobinuria (PNH) and atypical hemolytic uremic syndrome (aHUS), two life-threatening ultra-rare disorders.
- As the global leader in complement inhibition, our company is strengthening and broadening its portfolio of complement inhibitors, including evaluating potential indications for eculizumab in additional severe and ultra-rare disorders.
- Our company's metabolic franchise includes two highly innovative enzyme replacement therapies for patients with life-threatening and ultra-rare disorders
- In addition, our company is advancing the most robust rare disease pipeline in the biotech industry, with highly innovative product candidates in multiple therapeutic areas.
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