Regulatory Affairs Leader EU, Mechelen - BE, Basel - CH, Romainville, FR
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 Unites States (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’.
Due to our dynamic growth we are looking for a Regulatory Affairs Leader EU.
To provide regulatory scientific, strategic, and tactical expertise on the life-cycle management (LCM) of medicinal products registered in the Europe region (EEA, UK, and Switzerland). To ensure swift communication and follow-up on post-authorisation obligations and commitments and regulatory dossier updates between headquarters and the local affiliates. To ensure all life-cycle management activities are compliant, timely and in accordance to the defined and agreed strategy.
- Lead Europe region for post-authorisation regulatory activities for Jyseleca® and future Galapagos’ products
- Collaborate with global product development colleagues for the authoring of global regulatory strategies
- Ensure unified execution of Europe region regulatory lifecycle management strategy and submission plans in close collaboration with the submission teams and local affiliates
- Contribute to key documentation for product licence maintenance that may be required for internal decision making and external HA submissions and notifications, ensuring they meet the requirements set forth by the health authorities
- Work with medical affairs and commercial to ensure that all post-authorisation follow-up measures are implemented and all externally distributed materials meet the requirements set forth by the health authorities
- Act as the company representative for Europe region, for product life-cycle management activities to key Galapagos functions, other regions, local affiliates, health authorities and regulatory vendors
- Provide input to Europe region post-authorisation regulatory budget planning
- Keep abreast of developments in regulatory affairs and product development strategies and requirements in the external environment; inform and advise the internal organization.
- Ensure adequate tracking, archiving and records clean-out activities for assigned projects.
- Ensure full compliance with all applicable regulatory and legal requirements and ensure alignment to company processes
- Adherence to existing Galapagos Policies and Procedures and timely completion of relevant training.
Who are you?
- You have a university degree in health sciences, pharmacy, biological science, chemistry or related field.
- You have 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.
- You have a profound and demonstrated knowledge of the European and 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.
- Ability to assimilate information and present it in a way that is understandable by key stakeholders to enable discussion and decsison making
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…!