QP & Regulatory Lead - Therapeutic Radio-isotopes
Headline
Lead QP and Regulatory Activities as a new GMP radioisotope facility takes shape
Highlights
- Act as Qualified Person (QP) for batch certification and release, ensuring GMP compliance in the production of radioisotopes for targeted radiotherapy
- Lead regulatory strategy and dossier preparation, and serve as primary liaison with health authorities and project partners
- Support the development of our GMP facility and operations across disciplines
Job description
As part of its growing Targeted Radiotherapy programme, SCK CEN is developing a new GMP facility for radioisotopes production. To support this effort, we are recruiting a QP & Regulatory Lead.
During the project phase, you will take the lead in establishing the regulatory framework and batch release processes. Your responsibilities include:
- Develop the batch release strategy and ensure release processes are GMP-compliant and inspection-ready
- Provide regulatory and quality support for manufacturing process development, including risk assessments, criticality analysis, and the definition of a robust control strategy with appropriate documentation
- Ensure successful acquisition of the manufacturing authorization for the facility
- Lead regulatory dossier preparation and serve as the main point of contact with external project partners for regulatory affairs
- Liaise with health authorities during inspections and other regulatory interactions
- Support pharmaceutical quality system development and integration
- Provide regulatory and quality guidance on equipment, procedures, IT systems, validation activities, and review and approve documentation
- Organize and oversee training related to your scope of responsibility
Once operations begin, your role will focus on ensuring regulatory compliance, performing batch certification, and supporting continuous improvement:
- Perform batch review and make legal release decisions as Qualified Person
- Maintain regulatory dossiers and ensure timely updates
- Act as liaison with health authorities for regulatory notifications, inspections, and formal communication
- Provide support to ensure day-to-day GMP compliance during manufacturing operations
Job requirements
- Master’s degree in Industrial Pharmacy or Pharmaceutical Sciences
- Official recognition as a Qualified Person under EU regulations, with a minimum of 2 years' hands-on experience in batch certification and GMP-related quality decision-making
- Accreditation as a radiopharmacist is a plus
- Experience in regulatory dossier preparation and interaction with health authorities
- Strong background in GMP compliance, with in-depth knowledge of national and international regulations
- Excellent communication, leadership, and documentation skills
- A proactive, structured, and hands-on mindset
- Ability to work cross-functionally in a multidisciplinary team
- Willing to work in controlled areas subject to radiation protection measures