Regulatory Affairs CMC Leader Oncology - 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’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.
  

Who are you?

• University degree in health sciences, pharmacy, biological science, chemistry or related field.
• At minimum 10-15 years of industry experience with relevant experience in-depth experience within CMC and regulatory CMC in cell and gene therapy/oncology medicinal product development in the pharmaceutical/biotech industry and/or with regulatory authorities.
  
• 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.
• Attitude of reliability and attention to detail. Strong organization skills, a high degree of flexibility, resilience, and assertiveness are essential for success. Professional attitude towards external and internal contacts. Effective communication style and interpersonal behaviour. Proven mature people management and coaching skills. Able to work efficiently in a x-functional matrix organisation.
  
• ln addition, data gathering, problem solving, and analytical thinking skills are highly desirable.
• Strong verbal and written communicator in English language, 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…!