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 Head Regulatory Affairs North America & Global CAR-T Lead - Princeton, US
Scope of the job
The Head Regulatory Affairs Leader North America (NA) & Global CAR-T Lead is responsible for providing regional regulatory leadership and direction into the global development programs to support the development, registration, and life-cycle management of innovative medicinal products. For the CAR-T franchise specifically, this leadership role is further extended to direct global development activities, in a close collaboration with the Head of ATMPs and Biologics.
The responsibilities include developing regulatory strategies and detailed plans to ensure successful achievement of company objectives, participating in program core teams and governance forums, and managing regulatory agency interactions in support of development and registration strategies, as well as to develop the required regulatory capabilities in the US office.
Your role
- Obtain and maintain regulatory approvals for Galapagos’ products.
- Act as primary company liaison with the NA Health Authorities, with primary focus on the CAR-T franchise.
- Represent Regulatory Affairs on the assigned cross functional Development Team(s) and Governance bodies.
- Within the context of the global strategy, drive the development of sound NA regulatory strategies for regulatory applications including NDA/BLA, IND, meeting packages, special protocol assessments (SPA), and special designations (e.g. fast-track, orphan drug, breakthrough, RMAT). Set challenging, but achievable regulatory objectives/plans, striving for accelerated development timelines in accordance with the company business goals.
- For the CAR-T franchise specifically, drive the development of sound global regulatory strategies in close collaboration with the Head of ATMPs and Biologics.
- Assume accountability and strategic oversight for the content and preparation of all NA regulatory documents/submissions related to applicable programs.
- Actively participate in the creation and senior leadership review of key development documents and meeting packages.
- Manage and develop the NA external vendor and external experts network and relationships required to deliver regulatory documents and dossiers of high quality. Oversee NA Regulatory operations in close collaboration with the Global Regulatory Operations team. Ensure adequate tracking, archiving and records clean-out activities for assigned projects.
- Keep abreast of developments in NA regulatory affairs and drug development strategies and requirements; inform and advise the internal organization. Define, initiate, and lead input initiatives to calls for comments, especially in those areas where impact needs to be made to help achieve the company-wide efforts/business goals.
- Lead the regulatory team in the US office. Develop the regulatory capabilities and act as leader by mentoring, coaching, and developing people to fulfil their potential, while also delivering business objectives.
- Ensure full compliance with all applicable regulatory and legal requirements and ensure alignment in the company processes.
- Adherence to existing Galapagos Policies and Procedures and timely completion of relevant training.
