Pleased to meet you, we are Galapagos, a dynamic growing Biotech company with offices across Europe and in the US. We’re in the business of changing lives. In our quest to discover and develop life-improving medicines we go where no one has ever gone before. In every challenge we face, we see new opportunities. We pioneer for patients. We need thought leaders and rapid thinkers, entrepreneurs in spirit and status quo-fighters. Collaborative innovators and perseverant idealists. We need the best-in-class. In other words, we need you: The ‘make-it-happener’.
Scope of the job
We are looking for a highly motivated Regulatory Leader to join our EU Regulatory Affairs team. As a standing member of assigned CAR-T/cell therapy project(s), you will provide your regulatory scientific expertise while closely collaborating with our (clinical) development teams.
Your role
- Obtain and maintain regulatory approvals for Galapagos’ CAR-T/cell therapy products.
- Represent Galapagos to health authorities and regulatory vendors, and act as the primary regulatory contact for cell therapy drugs developed in collaboration with partner companies.
- Ensure full compliance with regulatory and legal requirements and ensure alignment in the company processes.
- Develop and provide regulatory strategy and tactics for effective compound development to the assigned development project teams and clinical development teams.
- Lead development milestone meetings and act as company representative towards health authorities.
- Represent Regulatory Affairs in cross functional project teams. Advise on, implement, and execute the regulatory strategy endorsed by the project teams.
- Lead the preparation, compilation, and ensure regulatory content quality check of scientific regulatory dossiers and briefing packages (e.g., IND, MAA, scientific advice, paediatric investigation plan, orphan drug designation). Establish a close working relationship with the other regulatory affairs team members.
- Stay updated on developments in regulatory affairs and drug development strategies and requirements; inform and advise the internal organization. Provide guidance to the assigned regulatory affairs liaison on the expected regulatory intelligence input.
