Technical Regulatory Writer
Walloon Brabant – Contracting
#RA #Pharma #CMC
Our partner is currently looking for a Technical Regulatory Writer to reinforce its teams. Our partner is a pharmaceutical company.
What are your responsibilities?
The Technical Regulatory Writer is involved in the company’s regulatory activities related to new & existing products, on a domestic or international basis. Activities focus on technical writing for Facilities, major and minor submissions. Here are your main tasks:
- Write CMC, “facility and equipment” parts and new files for WW regulatory File.
- Manage and schedule with SMEs and Site conformance (and Production, Validation and Quality Assurance) the writing/review process to ensure timely completion.
- 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
- Assess the change controls that relate to pure facilities and equipment matters or work with GRL teams for change controls impacting both CMC and facilities.
Who are you?
- You hold a master’s degree (in Life Sciences) or equivalent by experience
- You have a first experience in writing CMC (technical) parts of regulatory documents (registration files or variations).
- You have good Knowledge of biologic process and process equipment.;
- You have good communication and writing skills
- You are fluent (both written and spoken) in English
What can you expect?
Jefferson Wells offers you a permanent contract as consultant with an attractive salary package and will give you access to trainings in technical matters and soft skills. We will be your career partner for each step along the way.
You’re interested in this job? We kindly invite you to apply. Do you have any questions? You can contact Sophie Rolis: [email protected]
