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Regulatory Operations Officer, Mechelen, BE
Development - Regulatory Affairs
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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’ 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.
We are looking for a Regulatory Operations Officer, Mechelen, BE
The Regulatory Operations Officer provides day-to-day operational support to the regulatory affairs department to obtain and maintain regulatory approvals for Galapagos' products.
- Assist the regulatory team in the assembly of regulatory submission packages, performance of compilation quality checks, submission, and tracking of submission packages to regulatory authorities.
- Perform data entry and support the development organization in the preparation of adequate records and the coordination to maintain compliance in public transparency databases such as Clinicaltrials.gov and the EU clinical trials register.
- Assist in the compilation of presentations and regulatory operations metrics and reporting activities.
- Manage the literature ordering process for the regulatory department.
- Organize the medical translations / back-translations process for the regulatory department.
- Labelling tracking in eDMS and management of translations.
- Ensure adequate archiving and records clean-out activities. Assist in uploading regulatory documents and labelling, in regulatory library of the Galapagos Document Management System and eTMF System.
- Create templates, standard formats, and instruction manuals for defined regulatory documents and processes.
- Adherence to existing Policies and Procedures and timely completion of relevant training.
- Be the central contact person for the Health Authority Portals and keep oversight of the accesses.
One may get access to study specific sensitive and confidential data/information that must be treated with discretion within the regulatory department.
This position reports to the Regulatory Operations Team Leader. You will work in close collaboration with the members of the Regulatory Affairs department and with Galapagos' local affiliates.
- A1 Medical Secretariat / Modern Languages, or equivalent.
- At least 3 years of experience in administration in Clinical Research of Regulatory Affairs or Medical department within pharmaceutical, biotech or healthcare company.
- Experience in a CRO-environment and experience with electronic submission portals and databases are desirable.
- Reliable and attention to detail.
- Strong organization skills and a high degree of flexibility are essential to thrive in this role.
- Enjoy working in a team and a high level of professionalism towards external and internal contacts.
- Ability to grasp and follow administrative procedures for a variety of tasks that need to be conducted simultaneously.
- Digital proficiency.
- 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 a ‘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…!