Regulatory Affairs Leader - based in Mechelen, BE, Leiden NL or Basel CH
Pleased to meet you, we are Galapagos, a dynamic fast growing biotech company with offices in Europe, 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 ‘make-it-happeners’.
We are looking for a Regulatory Affairs Leader.
Scope of the job:
To provide regulatory scientific expertise as a standing member of assigned project and clinical development teams. To deliver and execute the regulatory strategy upon endorsement by the project team, in an effective and compliant manner throughout all phases of development.
- Obtain and maintain regulatory approvals for Galapagos’ products.
- Act as the company representative for drug development activities to health authorities and regulatory vendors.
- Be the primary Galapagos regulatory 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 strategy and tactics for effective compound development to the assigned development project teams and clinical development teams.
- Lead development milestone meetings and act as company representative towards health authorities.
- Implement and execute the regulatory strategy endorsed by the project team.
- Lead the preparation, compilation, and ensure regulatory content quality check of scientific regulatory dossiers and briefing packages (e.g. IND, MAA, scientific advice, paediatric investigation plan, orphan drug designation).
- Keep abreast of developments in 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.
Who are you?
Education & experience:
- University degree in health sciences, pharmacy, biological science, chemistry or related field.
- At minimum 10-15 years of relevant experience in medicinal product development in a broad range of regulatory affairs projects 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.
- 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…!