This position is open for candidates with a first experience in Regulatory Affairs (internship or working experience) or with experience in an administrative position within the pharma industry.
For this role, good knowledge of French, Dutch and English is required.
As RA/Labelling officer, you comply with the Company's policies and procedures to assure consistency of the current local prescribing information with the CCDS and/or EU labelling in order to ensure alignment within the organization; meet the expectations of regulatory agencies; implement approved label through defined artwork process.
You act as Variations Officer & Label Operator
You act as local expert for the available Regulatory Data Management Systems and ensure robust systems are in place for high quality data population
- You work with the appropriate electronic systems soon after a new safety and indication/efficacy information becomes available or the content of the CCDS may change
- According to the Company's procedures, you assess the documentation, propose the submission strategy and timelines to the Manager and then submit the change to the Regulatory Authorities. Appropriate communication within the organization should be done as required
- When new labelling is approved, you work closely with appropriate electronic systems and Label centers to get labels developed, approved and implemented as per the required timeframe. You ensure coordination and maintain oversight of all labelling activities, including those performed by other team members.
- You proactively communicate to Head of Regulatory Affairs and QA Manager on potential issues
- You work closely with Supply chain in order to anticipate any back order of the products on the market
- You assist in the Development of Regulatory Affairs SOPs in compliance with the local regulation and internal policies and procedures
- You liaise with Western European Regulatory Affairs and Corporate groups on regulatory and labelling matters
- You check promotional materials for compliance with current approved labelling and pricing information.
- You have a bachelor degree in Life Sciences or a degree in an administrative orientation
- You have an admin experience in the pharma industry or a first experience in Regulatory Affairs (internship or working experience)
- You are bilingual English and French or Dutch with a good knowledge of the second national language
- You have Project Management and Strategic Communication skills
- You are accurate end efficient
- You have strong Organizational skills (proven experience) and sense for initiative
- You can perform multiple tasks and to establish priorities
- You are computer literate: Ms Word, Ms Excel, Acrobat
- Existing right to work in Europe is required
- Fulltime or 80%
- Hybrid working opportunity (2 days/week on Site in Wavre + 3 days/week home-based)
- Competitive salary with extra legal benefits
- Long-term position