Job content

You participate in missions related to Quality:
• Organize monthly meetings within the subsidiaries with the head office.
• Actively participate in internal and external audits and local authority inspections.
• Analyze current quality assurance processes in GxP operations, define performance measures and make continuous improvements.
• Provide guidance regarding compliance with quality policies and procedures.
• Participate in various quality / compliance projects.
• Review CAPA files, complaints, SOPs and investigate deviations or non-conformances.
• Represent the company in the relevant committees of the professional associations (Bachi – Pharma.be, …).
• Act as Benelux compliance officer, responsible for compliance committee meetings, all compliance related issues, HCP compliance procedures & trainings, report compliance KPI’s.

You participate in missions related to Regulatory :
• Facilitate the preparation of specific regulatory requests (import requests, post marketing follow-up, etc.).
• Establish, monitor and control regulatory conformity as well as the submission of AMM in accordance with the established schedule.
• Carry out a regulatory monitoring.
• Analyze and evaluate product-related risks.
• Organize, plan and write procedures inherent to regulatory affairs activities.
• Supervise the traceability and archiving of regulatory documents.
• Contact with health authorities on regulatory conditions.
• Monitor Pharmaceutical laws in all 3 countries (Benelux) and ensure operational compliance (advertising, congress, packaging, samples, pharmaceutical SOP, …).
• Handle objections (authorities) with the support of the Corporate Regulatory Affairs Department.
• Ensure that all necessary regulatory adequate procedures are in place to assure the pharmaceutical responsibility of the Benelux.
• Review all packaging artworks from a regulatory perspective as per internal an Corporate SOP’s in place.
 

Your RIP and Pharmacovigilance back-up responsibilities :
• Responsible for communication compliance towards HCP & publicity approval.
• Responsible for all promotional activities (materials, sampling reporting to government, congress visa and promotional literature) in Benelux.
• Possibility to act as RIP is an asset.
• Act as back-up local safety officer.
• Has a link with the EU Qualified Person for Pharmacovigilance (EU QPPV).
• Clinical Trials: monitor, together with the team, Regulatory & Promotional Clinical Trials as suggested by Drug Authorities and Marketing Department (Phase IV, Obs study).

Your strengths ?
Master in Pharmaceutical sciences, Biomedical sciences, Bio Engineering, Biochemistry, …
Also, a first experience in the pharmaceutical industry and/or in the consulting sector as well as knowledge of the regulatory field would be a plus.
You have excellent knowledge of validation and qualification. Experience with GxP is required.
Finally, you are fluent in Dutch as well as English and French (French and/or Dutch mother tongue!)
About you ?
You are known for your organizational skills and rigor. Your strength of proposal and your team spirit will be your best assets.