Head Regulatory Affairs Oncology - Leiden, NL or Mechelen, BE

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 Oncology to join our team in Leiden, the Netherlands or Mechelen, Belgium. 

Scope of the job

Lead and develop the team of regulatory affairs leaders, liaisons, and CMC leaders to ensure high quality regulatory strategic expertise, tactical and operational excellence is provided across all projects of the Oncology therapeutic area. Ensure the regulatory strategy as endorsed by the therapeutic area is delivered and executed in an effective and compliant manner throughout all phases of development and assigned geographies.

Ensure a well-managed and balanced headcount, with timely and fit-for-purpose resourcing, key capabilities covered by adequate expertise, and making use of external / flexible resources as needed.

Act as leader by giving strategic and tactical direction to your team and by mentoring, coaching, and developing people to fulfil their potential, while also delivering business objectives.

Your role

• Accountability and responsibility for obtaining and maintaining regulatory approvals for Galapagos’ products in the assigned therapeutic area and associated geographies.
• Effectively manage the required resources and develop the team. Foster an environment of trust, teamwork, diversity, and effective working to enable each employee, department, and the organization to succeed.
• Running day-to-day operations, including internal team meetings to develop and provide well-informed regulatory strategy and tactics for effective compound development to the assigned product development teams.
• Ensuring effective communication with Head Regulatory Affairs, Regulatory Affairs staff, senior management and major stakeholders across the organization.
• Represent regulatory affairs in the assigned therapeutic area and product development teams, as required. Advise on, implement, and execute the regulatory strategy endorsed by the therapeutic area.
• Lead development milestone meetings and act as company representative towards health authorities for drug development and maintenance activities to health authorities and regulatory vendors.
• Be the primary Galapagos regulatory contact point for drugs developed in collaboration with partner companies.
• Ensuring full compliance with all applicable regulatory and legal requirements and ensure alignment in the company processes.
• Keep abreast of 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.
• Ensure adequate tracking, archiving and records clean-out activities for assigned projects.
• Lead the preparation, compilation, and ensure regulatory content quality check of scientific regulatory dossiers and briefing packages (e.g., IND, MAA, scientific advice, pediatric investigation plan, orphan drug designation, as needed.
• Adherence to existing Galapagos Policies and Procedures and timely completion of relevant training.