TECHNICAL REGULATORY WRITER W/M

Job description

As a major European player in clinical research, Keyrus Biopharma is a CRO (Contract Research Organization) created in 1998 which has 250 employees spread across several sites in Europe and having its HQ in France (Paris).
Keyrus Biopharma has focused its development strategy on innovation and creativity to offer its customers added value solutions. We specialize in all clinical service areas: regulatory strategy and submissions, feasibility studies, PV and drug safety, study implementation and monitoring, data management, biostatistics and scientific writing.
We are seeking a Technical Regulatory Writer w/m.
Main tasks:
- The Technical Regulatory Writer is involved in the regulatory activities related to new and existing products , on a national or international basis.
- Writing CMC parts of regulatory variations
- Writing Module 2 of regulatory files derived from completed eCTD Modules 3
- Writing IMPDs,
- Writing Responses to Questions raised by Regulatory Authorities on CMC matters
- Update of internal tracking system linked to their CMC activities
- Involvement in internal initiatives for improvement of processes/ ways of working
Required skills and qualities and expected level
- Very Good level of English (spoken and written)
- Knowledge of regulatory procedures / systems / guidances
- Knowledge of the EU / US variations policy
- Manage own time to meet agreed short term targets
- Ensure the coherence between contributions / quality of final results
- Team player
Required level of education:
- Scientific University Degree / Master in Pharmacy
Required work experience in this rol
- Experience in writing CMC (technical) parts of regulatory documents (registration files or variations)for EU, US and International
- Experience working in Biologics (if possible preferred over Pharmaceuticals)
- Experience in research laboratory or in regulatory/drug development/ public health organization
Come and join us in Belgium !
What are the advantages to work at Keyrus Biopharma Belgium?
- You will boost your career at the international level. You will work with colleagues from all over the world on global projects. You will work with international teams, projects and clients!
- You will enjoy the famous Belgian culture focused on open, simplicity and work-life balance!
- You will have a high quality of life in Belgium (Cost of life lower than other EU big capital cities), famous Belgian gastronomy, lots of green areas…).
- You will work in our offices located in the middle of countryside. You will have the opportunity to attend some internal events, to do sport with colleagues, to possibly work from home if needed and to have flexibility in your working hours.
- Brussels is also a crossroads in Europe. If you like travelling, don’t miss the closest cities like Paris, London or Amsterdam!
- Each new comer is welcomed with a varied integration program. We invest considerable time and resources in training our staff (technical and non-technical courses). You will join a dynamic and international environment with enthusiastic and professional colleagues.
Interest ? Please send your resume and motivation letter in English.