Regulatory Affairs CMC Director - Leiden, NL

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 are in the business of changing lives. Focusing on high unmet medical needs, we synergize compelling science, technology, and collaborative approaches to create a deep pipeline of best-in-class medicines. With capabilities from lab to patient, including a decentralized cell therapy manufacturing platform, we are committed to challenging the status quo and delivering results for our patients, employees, and shareholders. Our goal is not just to meet current medical needs but to anticipate and shape the future of healthcare, ensuring that our innovations reach those who need them most.

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 Director - Leiden, NL or Mechelen, BE.

Scope of the job

Are you ready to lead in the world of regulatory affairs?

In this role, you get the opportunity to provide regulatory scientific CMC (Chemistry, Manufacturing, and Control) cell and gene therapy/oncology expertise and leadership. And this with a focus on the EU both to the Regulatory Affairs team as the CMC team. Additionally, you get the chance to work throughout all phases of drug development and lifecycle management, and this in an effective and compliant manner.

Your role

• Regulatory Approvals: You obtain and maintain regulatory approvals for our cell/gene therapy products.

• Company Representative: You act as the face of Galapagos for drug development CMC activities with EU health authorities and regulatory vendor.

• Knowledge: You serve as the EU regulatory oncology/cell therapy CMC expert.

• Collaboration: You are the primary regulatory CMC contact point for cell/gene therapy drugs developed in collaboration with partner companies.

• Strategic Guidance: You develop and provide regulatory CMC strategies for effective compound development to the regulatory affairs and CMC teams.

• Dossier Management: You 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).

• Global Interactions: You prepare for and follow up on formal CMC scientific and regulatory interactions with EU regulatory agencies.

• Stay Updated: You keep abreast of developments in CMC regulatory affairs and drug development strategies and requirements; inform and advise the internal organization.

• Compliance: You ensure adequate tracking, archiving, and records clean-out activities for assigned projects. Furthermore, you ensure full compliance with all applicable regulatory and legal requirements and alignment with company processes.

• Policies & Procedures: You adhere to existing Galapagos Policies and Procedures and timely complete relevant training.

Who are you?

• Education: You have a Master’s Degree in health sciences, pharmacy, biological sciences, chemistry, or a related field.

• Experience: You bring at 8 to 15 years of biotech industry experience, with in-depth expertise in CMC and EU regulatory affairs. Ideally within the cell and gene therapy/oncology space, though this is a not a must. Experience within Car-T-technology is a plus.

• Knowledge: You possess a profound and demonstrated knowledge of the international regulatory affairs environment with a sound understanding of the pharmaceutical/biotech business-environment. Proven experience in Health Authority interactions, with a focus on the EU.

• Skills: You have strong organization skills, a high degree of flexibility, resilience, and assertiveness, which are essential for success. You maintain a professional attitude towards external and internal contacts and display effective communication style and interpersonal behavior. Proven mature people management and coaching skills. You are able to work efficiently in a cross-functional matrix organization.

  You also possess strong data gathering, problem-solving, and analytical thinking skills.

  You are a strong verbal and written communicator in English, and being multilingual is an asset.

  
  

What’s in it for you ?

At Galapagos, we prioritize your continuous growth and development, fostering a culture of empowerment. Our employees are the driving force behind our mission to lead in pharmaceutical research and innovation.

We offer a competitive compensation package and a supportive work environment with strong focus on your health and well-being. Join us in our journey towards sustainability, as we strive to make a lasting impact on both the industry and the planet.

We are Galapagos: together we can make it happen…!