Do you have a first experience in Regulatory Affairs, especially within the pharmaceutical industry? Are you looking for the next step in your career? Then this great opportunity as Regulatory Affairs Writer might be your next challenge !
On site role at the Client location in Belgium : 2 days/week + home based 3 days/week
Job Description
The Regulatory Affairs Writer is a Member of Equipment Integrity Program. The RA Writer is responsible for writing scientific reports, that will be used for inspections (FDA) and audits and build a presentation support (power point) based on the report to facilitate the presentation in audit.
Responsibilities
- Define the structure of the report and the slide deck
- Organize the way to collect all information needed to write it
- Write the report and the slide deck
- Report must include all information related to contamination as batches produced during the period, QC labs results, investigation results, Quality decisions, all remediation/corrective actions
- The report and associated slide deck must be in perfect English with high standard of Authorities presentation
Requirements
- University degree in Sciences
- Experience on file or scientific report writing
- Experience in authorities Inspection / Audit
- Experience in the Pharmaceutical industry
- Knowledge of GMP
- Administrative task competency (Word / Visio / Power Point)
- Conscientious
- Autonomous
- Team player
- Fluent in English and basic level in French
- On site role at the Client location in Belgium : 2 days/week + home based 3 days/week
Benefits
- A balanced salary package based on your capabilities and experience, including meal vouchers.
- Full time position (open for freelancers or employees)
- Flexibility between home/office-working
Vacancy number: 20368
