Regulatory Submissions Process Manager - Mechelen,BE/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 an Regulatory Submissions Process Manager - Mechelen,BE/Leiden,NL

Core Purpose of Job:

You will be responsible to work with the Regulatory Submission Strategy Team (RAST) on the development of the submission dossiers (global and regional). The global submission dossier needs to provide a global as well as regional context to ensure that filing and regulatory compliance objectives will be met. The submission plans will need to be developed in close collaboration with the respective Regulatory Leader(s) and the assigned Regulatory Project Manager (RPM), as applicable, with input from the respective functional area topic experts. This also includes the planning and execution of post approval commitments and life cycle management.

Principal Accountabilities:

  • Core member of the RAST, reporting into the applicable project/product team, with a link to project/product team.
  • Co-lead of submission strategy meetings in partnership with the assigned Regulatory Leader and local regulatory affairs representatives, when applicable.
  • Contribute to the development of a granular submission project plan for the (global) submission dossier in collaboration with the Regulatory Leader and RPM (if applicable), and generate a derived, detailed submission content plan. The submission plans should contain granular preparation and review timelines, including identification of document owners, authors, reviewers and approvers, focused on the critical and near critical phase, with timely identification and execution of non-critical path activities in advance of the critical phase.
  • Execute the submission plans with relevant internal stakeholders.
  • Manage the assembly of the submission package with the Authors and handover the final documents to the RDMS Publishing team. Ensure the completeness of the source references is checked and perform a Quality Check (QC) of the published output is performed. Manage the translation process (if applicable).
  • Ensure that the regulatory actions are planned in the relevant Regulatory Information Management (RIM) system/tracker and regulatory activity progress is tracked and monitored in this system.
  • Provide an overview of the initially agreed and updated (if applicable) timelines for information sharing with the relevant internal stakeholders.
  • Track post-approval commitments.
  • Act as the Europe region company representative for regulatory submissions to key Galapagos functions, other regions, local affiliates, health authorities and regulatory vendors.
  • Conduct lessons learned/document best practices post submission.

Job requirements

Who are you?

  • More than 7 years’ experience with major EMA/EU submission(s) and regulatory submission project management.
  • Thorough understanding of eCTD structure, modules and interlinks, and resource needs.
  • Project management expertise in other area’s of drug development will be an asset.
  • Thorough understanding of the drug development process.
  • Having experience in collaboration projects
  • Be an expert in using planning tools 
  • 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…!