(Junior) Regulatory Affairs Manager
+32 494 04 21 32
Description de l'emploi
The (Jr) Regulatory Affairs Manager works under the hierarchical supervision of the Head of Regulatory Affairs.
The Regulatory Affairs Manager operates within the Regulatory Affairs Unit (RAU) to ensure that all the regulatory requirements pertaining to clinical research are fulfilled.
- Prepare master packages for international clinical trial applications
- Provide regulatory advice to staff on applicable legislations (international and national) and regulatory procedures
- Compile, submit and follow-up clinical trial applications according to applicable national laws
- Ensure timely answers to questions raised by Competent Authorities and Ethic Committees
- Interact with Pharmaceutical Industry and Contract Research Organizations (CRO) for specific projects
- Ensure at any time compliance with procedures in changing legal environment
- Contribute to and maintain databases for assigned trials.
- Contribute to training/coaching of new regulatory team members
- Master’s degree in life sciences or related field
- 1-5 years’ prior experience including demonstrable experience in Site activation/Regulatory Affairs related to clinical trials environment (CRO or university/ hospital or pharmaceutical industry) or equivalent combination of education, training and experience
- Familiar with the EU Clinical Trials Regulation N° 536/2014 and knowledgeable on the new upcoming European regulations
- Ability to cope with and meet tight timelines when required
- Able to manage multiple tasks at the same time
- Able to work independently as well as part of a team
- Demonstrated good organization, communication and time-management skills
- Excellent attention to detail and accuracy
- Proficient verbal and written English, other language is an asset