Job Description
As Regulatory Affairs/Site Activation Manager you operate within the Regulatory Affairs Department. Your role is to ensure the fulfillment of all the legal requirements pertaining to clinical trials activation in countries where clinical trials are conducted. The level of responsibilities will depend on your experience and expertise in the field.
Responsibilities
- You compile, submit and follow-up clinical trial applications according to the country specific applicable national laws
- You ensure timely answers to questions raised by Competent Authorities and Ethic Committees
- You provide regulatory advice on applicable national legislations and regulatory procedures
- You interact with Pharmaceutical Industry and Contract Research Organizations (CRO) for specific projects
- You ensure at any time compliance with the company's procedures in changing legal environment
- You have a university degree in life sciences or related field, with 3 years of relevant experience including demonstrable experience in Site activation/Regulatory Affairs related to clinical trials environment (CRO or university/ hospital or pharmaceutical industry).
- You are familiar with the EU Clinical Trials Regulation N° 536/2014 and knowledgeable on the new upcoming European regulations
- You are fluent in English. Any other language is an asset
- You have the ability to cope with and meet tight timelines when required
- You are able to manage multiple tasks at the same time
- You are able to work independently as well as part of a team
- You demonstrate good organization, communication and time-management skills
- You have an excellent attention to detail and accuracy