Pleased to meet you, we are Galapagos, a dynamic
growing Biotech company with offices across Europe and in the US,
headquartered in Mechelen, Belgium.
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’.
We are looking for a Regulatory Affairs CMC Leader Oncology - Leiden, NL
Scope of the job
Provide regulatory scientific Chemistry, Manufacturing, and Control (CMC) cell and gene therapy/oncology expertise and leadership to the Regulatory Affairs team and the CMC team, on a global scale and in an effective and compliant manner throughout all phases of development and lifecycle management. The primary focus of this job is directed to the oncology portfolio, with support to immunology projects where relevant.
Your role
- Obtain and maintain regulatory approvals for Galapagos’ cell/gene therapy products.
- Act as the company representative for drug development cell/gene therapy CMC activities to health authorities and regulatory vendors. Serve as the global regulatory oncology/cell therapy CMC expert.
- Be the primary Galapagos regulatory CMC contact point for cell/gene therapy drugs developed in collaboration with partner companies.
- Develop and provide regulatory CMC strategy and tactics for effective compound development to the regulatory affairs and CMC teams. Provide strategic and tactical input in regulatory CMC dossiers (e.g. Quality IMPDs, Module 3 and QoS documents for INDs or marketing authorisations, CMC lifecycle management dossiers).
- Prepare and follow-up on formal CMC scientific and regulatory interactions with global regulatory agencies.
- Keep abreast of developments in CMC regulatory affairs and drug development strategies and requirements; inform and advise the internal organization.
- Ensure adequate tracking, archiving and records clean-out activities for assigned projects.
- Ensure full compliance with all applicable regulatory and legal requirements and ensure alignment to company processes.
- Adherence to existing Galapagos Policies and Procedures and timely completion of relevant training.
