For one of our clients located in the east of Brussels, we are looking for a RA/Site Activation Manager.
Job Description
As RA - Site Activation Manager, you operate within the Regulatory Affairs Department. You ensure the fulfillment of all the legal requirements pertaining to clinical trials activation in countries where clinical trials are conducted.
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 Industries and CROs for specific projects
- You ensure at any time compliance with procedures in changing legal environment
Requirements
- You have a university degree in life sciences or related field and a first experience in Site activation/Regulatory Affairs related to clinical trials
- You have knowledg og EU Clinical Trials Regulation N° 536/2014. Knowledge of the new upcoming European regulations is a strong 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 have good organization, communication and time-management skills
- You are proficient in English (speaking and writing), other language is an asset