For one of our clients in the pharmaceutical industry, we are currently looking for a Technical Regulatory Writer.
- Write CMC, "facility and equipment" parts and new files for regulatory File.
- Compile and write regulatory documentation in accordance with regulatory requirements.
- Ensure the coordination with the departments involved in the writing/review process
- Write and support regulatory affairs Responses to Questions raised by Regulatory Authorities
- Monitor that supportive data provided by other departments are compliant.
- Report significant issues
- University level (Life Sciences background is preferred) or equivalent by experience
- Experience in writing CMC (technical) parts of regulatory documents (registration files or variations)
- Experience working in validation/QA/production in Biologics/Pharmaceuticals industry
- Knowledge of regulatory procedures/systems/guidance's
- Good level of spoken and written English
- Knowledge of biologic process and process equipment
- Knowledge of Qualification/Validation principles
We offer you an open-ended contract as well as an attractive salary package. You will also take advantage of the opportunity to develop yourself personally and professionally through internal training. Interested? Do not wait any longer !
Apply directly via our website www.experis.be or send your CV to the following email address