Ref: MEC 172
The Regulatory Affairs Liaison (specialty CMC) is responsible for managing the day-to-day support activities to obtain and maintain regulatory approvals for Galapagos’ products, with primary focus on the overall regulatory aspects of clinical trial submissions and a specialty in CMC documentation. The Regulatory Affairs Liason (CMC) is a standing member of assigned clinical working groups and is the primary regulatory liaison with the CMC department.
University degree in health sciences, pharmacy, biological science, chemistry or related field.
At minimum 5 years of relevant experience in CMC regulatory affairs in a range of projects, and including writing of CMC documents.
Previous experience in the development of fixed-dose combination products is an advantage.
Demonstrated attitude of reliability and attention to detail. Strong organization skills, a high degree of flexibility, resilience, and assertiveness are essential for success. Professional attitude towards external and internal contacts. In addition, data gathering, problem solving and analytical thinking skills are highly desirable.
Strong verbal and written communicator in English language, multilingual is an asset.