We are looking for a Regulatory Affairs Technician to join the team of our client an important company of the pharmaceutical industry.
.Compile, write, review and publish registration dossiers for new product registrations by applying solid international regulatory knowledge and CMC expertise.
. Collaborate effectively with internal partners and global clients for the maintenance of marketing authorizations of all out-licensing activities.
. Consolidate authorized dossiers and perform regulatory activities to ensure regulatory compliance.
. Coordinate working groups for the effective response to deficiency comments from international regulatory agencies and author response documents with support from working groups.
. Provide regulatory support and insight to internal and external partners.
. Collaborate with service providers and coordinate activities with internal/external partners to meet regulatory objectives.
. Maintain regulatory database on a daily basis.
. Coach other junior regulatory specialists in the department.
. Participate in product development activities and periodic meetings with upper management
· +3 years experience experience in Regulatory Affairs Pharma departments.
· Academic Degree in Life Science
· Advanced IT level - (MS Office)
· Proactive, good communication, accurate, detail orientated.
A highly professional, dynamic, ambitious working environment.
Initial salary: 35.000 euros gross year +10% variable
40% remote work
Permanent position. The hiring bill be done directly by this company.