Regulatory Affairs Liaison - Mechelen, BE
Pleased to meet you, we are Galapagos, a dynamic fast growing Biotech company with offices in Belgium (Mechelen), France (Romainville), the Netherlands (Leiden), Switzerland (Basel), and in the US (Boston).
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 want to challenge the impossible. 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 ones who ‘make-it-happen’.
We are looking for a Regulatory Affairs Liaison
Scope of the job
The Regulatory Affairs Liaison is responsible for managing the day-to-day support activities to obtain and maintain regulatory approvals for Galapagos’ products, with primary focus on the overall regulatory aspects of Clinical Trial Applications. The Regulatory Affairs Liaison is a standing member of assigned clinical working groups.
- Coordination, preparation, submission, maintenance, and compliance of regulatory aspects in clinical trial applications, in close collaboration with the assigned Regulatory Lead.
- Assist in the preparation and compilation of scientific regulatory dossiers and briefing packages (e.g. scientific advice, orphan drug designation).
- Regulatory intelligence: stay current with changes in regulatory requirements and inform and advise the internal organisation. Assist in the preparation of regulatory guidance summaries to support and facilitate strategic decision-making.
- Records Retention: ensure adequate tracking, archiving and records clean-out activities for assigned projects.
- Assist in the compilation and implementation of defined procedural documents and processes for the department.
Who are you ?
- University degree in health sciences, pharmacy, biological science, chemistry or related field.
- Min. 5 years of relevant experience in regulatory affairs in a range of projects, and including writing of regulatory documents.
- Data gathering, problem solving and analytical thinking skills are highly desirable.
- Demonstrated 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.
- Proficiency in the common software and computer skills.
- Strong verbal and written communicator in English language, multilingual is an asset.
- This is a fast-paced environment; you must be able to multi-task and adapt to change
- Effective interpersonal skills to work well in a matrix team environment and with international colleagues at all levels in the organization.
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…!