Quality & Regulatory Affairs Manager – Brussels – Permanent
Nicholas Howard Limited are delighted to be recruiting for a new and exciting role as a Quality & Regulatory Affairs Manager.
Based in Brussels, the successful candidate will assume all responsibilities of the Regulatory Affairs Manager for Belgium, Luxembourg and the Netherlands.
Main responsibilities include: –
- Is in charge of the local regulatory intelligence and all related tasks.
- Is the contact person dealing with the authorities for RA on his/her perimeter.
- Checks the legal and regulatory compliance as well as the scientific content of the documentation sent by the Corporate RA department.
- Submits variations, renewals or new marketing authorization applications to his/her competent authority. Attaches any relevant documentation according to the local requirements. Translates some documents in French or Dutch.
- Is in charge of the follow-up of the pending approvals. Answers some questions and provides additional documentation when requested by the agency. Informs the Corporate RA department about the approval status of the dossiers.
- Informs the Corporate RA department about new regulations on his/her perimeter.
- Proposes regulatory strategies based on his/her expertise and knowledge of the laws from Belgium, Luxembourg and the Netherlands about medicines.
- Revises and validates the texts of the packaging materials of the products.
- Applies for pricing and reimbursement of the products and follows the decisions of the commissions.
- Is in charge to submit all PV related issues such as the PSURs, new SmPCs and other safety related documents to the competent authority.
Education & Experience:
- Pharmacist or scientist with sufficient legal qualifications and experience to locally manage RA and QA activities. This includes general GMP and Quality expertise, to act as Responsible Person.
- Fluent in Dutch and French. Good level in English.
To be considered for this position please apply below.