REGULATORY AFFAIRS - TECHNICAL WRITER H/F

Job description

Keyrus Biopharma is an international Consulting, Contract Research Organisation and Functional Services provider with a reputation for transparency and integrity, highly focused on being able to deliver with excellence. Our ‘human’ approach to service provision is what differentiates us from our competitors. Combined with our high caliber staff, this approach has allowed us to become a key player in clinical research.
At Keyrus Biopharma we’re proud of our commitment to delivering services of the highest quality, not only skillfully, efficiently and reliably, but also with sincerity and genuine care for our clients’ projects, priorities and reputation. Thus we maintain and advance our vision and our standards, all the while ensuring that we serve your interests better
From early
- to late-stage drug development, our range of services includes: Project Management, Clinical Operations, Pharmacovigilance, Quality Assurance (GxP), Regulatory Affairs Strategy & Support, Data Management, Medical Review & Coding, Biostatistics, Medical Writing & Medical Information, Real World evidence services.
Keyrus France Office:
- 18/20 rue Clément Bayard
- 92300 Levallois-Perret
Keyrus Belgium Offices:
- Chée de Louvain 88
- Waterloo-Lasne
- Rue Emile Francqui, 1
- Mont-Saint-Guibert
- Nijverheidslaan 3,
- Strombeeck Bever
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.