Regulatory Affairs CMC Leader - based in Mechelen, BE or Leiden NL

Job description

Pleased to meet you, we are Galapagos, a dynamic fast growing Biotech company. We’re in the business of changing lives.


Galapagos’ mission is to make a lasting positive contribution to society through discovery of innovative therapies for diseases with large unmet medical need. Galapagos seeks to develop a robust portfolio of therapies that have the potential to revolutionize existing treatment paradigms. The company’s ambition is to become a leading global biopharmaceutical company, focused on the discovery, development and commercialization of innovative medicines to improve patients’ lives. Galapagos’ historic focus on developing first-in-class medicines based on the discovery of novel targets in inflammation and fibrosis has led to the successful launch of our first medicine in rheumatoid arthritis in 2020 and in ulcerative colitis in 2021. The pivotal study in Crohn’s Disease is fully recruited and we expect topline data and potential approval in this new indication in a couple of years.

Galapagos is now entering an exciting new chapter to expand and diversify its pipeline for the future, starting with oncology, specifically CAR-T cell-therapy, a transformative treatment of different types of cancer. Through the combined acquisitions of CellPoint and AboundBio, we are propelling ourselves into next-generation cell therapies. CellPoint brings a novel, decentralized point-of-care cell therapy manufacturing model, which has the potential to offer efficient, 7-day time to treatment and avoids complex logistics, resulting in potential better patient outcomes and broader access. AboundBio’s cutting-edge fully human antibody-based platform provides access to a research engine for next generation multi-targeting CAR-Ts that have the potential to deliver deeper and durable clinical responses and that will be developed using CellPoint’s decentralized model.

We are looking for a Regulatory Affairs CMC Leader - Mechelen, BE/Leiden,NL


Scope of the job:

To provide regulatory scientific CMC expertise and leadership to the Regulatory Affairs team, the CMC and the New Product Introductions (NPI) team, on a global scale and in an effective and compliant manner throughout all phases of development and lifecycle management.

Principal Accountabilities:

  • Obtain and maintain regulatory approvals for Galapagos’ products.
  • Act as the company representative for drug development CMC activities to health authorities and regulatory vendors. Serve as the global regulatory CMC expert.
  • Be the primary Galapagos regulatory CMC contact point for drugs developed in collaboration with partner companies.
  • Ensure full compliance with all applicable regulatory and legal requirements and ensure alignment in the company processes.
  • Develop and provide regulatory CMC strategy and tactics for effective compound development to the regulatory affairs, CMC and NPI 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.
  • Adherence to existing Galapagos Policies and Procedures and timely completion of relevant training.

#LI-LB

Job requirements

Who are you?

  • University degree in health sciences, pharmacy, biological science, chemistry or related field.
  • At minimum 10-15 years of in-depth regulatory CMC experience in small molecule medicinal product development in the pharmaceutical/biotech industry and/or with regulatory authorities. Additional expertise in biologicals is an asset. A profound and demonstrated knowledge of the international regulatory affairs environment with a sound understanding of the pharmaceutical/biotech business-environment.
  • 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. In 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 ?

You will be part of a fast growing and amazing company. As ‘make-it-happener’ you will get all the support you need to make your job successful. At Galapagos we aim to recruit the best people, who stand out among their peers, with integrity and excellent interpersonal and organizational skills. Our employees are the strength behind Galapagos, a highly motivated team, eager to maintain Galapagos’ leading position and achieve breakthroughs in pharmaceutical research. Galapagos offers a competitive remuneration package and a dynamic work environment.

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