Regulatory Submission Specialist (Belgium)

Regulatory Submissions Specialist - Flexible workstyle - Belgium - Permanent

Here at ARM, we are actively looking for bright candidates with Regulatory submission experience to join at a specialist level for a leading CRO who have great reputation for their Submissions team in Germany. Having placed 9 candidates within this team, we believe that we would be able to provide you the support and information about the role, the fantastic work environment and various development opportunities that are in place for the candidates.

What your main duties involve:

Preparing, reviewing, and coordinating local regulatory submissions
Providing guidance of local regulatory strategy advice to various sponsors
Point of contact at country level for Ethical and Regulatory submission-related activities
Working with the clinical team to prepare the regulatory compliance review packages
Ensure the local country study files and filing processes

What we would like to hear about you:

About your educational experience and/ or relative experience or training
About your clinical experience/ submissions experience
About your effective oral and communication English and Dutch or French
About your basic knowledge of regional/ country level regulatory guidelines and EC regulations

Disclaimer:

This vacancy is being advertised by either Advanced Resource Managers Limited, Advanced Resource Managers IT Limited or Advanced Resource Managers Engineering Limited ("ARM"). ARM is a specialist talent acquisition and management consultancy. We provide technical contingency recruitment and a portfolio of more complex resource solutions. Our specialist recruitment divisions cover the entire technical arena, including some of the most economically and strategically important industries in the UK and the world today. We will never send your CV without your permission.