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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.