Healthcare Regulatory Coordinator
Biotechnology is at the forefront of transformative, cutting-edge and research-intensive scientific advancements. Enabling wide-scale societal change, biotechnology underpins innovation to address and revolutionise how patients are treated and provide sustainable, resource-efficient, climate-friendly products and processes.
Biotechnology has unprecedented policy focus entering into the new Commission mandate and Europa Bio has the opportunity to deliver impactful regulatory frameworks for this globally strategic technology.
Europa Bio, the voice of Europe’s dynamic biotechnology industry, is currently seeking a motivated Regulatory Affairs coordinator to join the Healthcare Biotechnology Team for an indefinite period.
Europa Bio has an opportunity for a successful applicant to take initiative and become a champion within Regulatory Affairs for innovative biotechnology in healthcare. The successful candidate will be able to coordinate the delivery of Regulatory Affairs initiatives in Europa Bio, as primary point of contact for members and stakeholders, with a strong focus on career development within an association.
The role includes:

• Work closely alongside the Healthcare Team to create a complete service for impactful advocacy for biotechnology.
• Support the development of Europa Bio activities within the field of healthcare biotechnology and pharmaceutical regulation, representing member priorities
• Act as primary lead for the Regulatory Affairs Working Group and a sub-WG with a specific focus on the implementation of the Clinical Trials Regulation
• Act as liaison between members and the European Medicines Agency and European Commission
• Support regulatory aspects of other Europa Bio Healthcare Working Groups, including ATMPs and OMPs, plus the National Associations Council
• Support the implementation of Europa Bio strategy for healthcare advocacy, including translation of regulatory priorities into impactful activities,
• Support healthcare contribution into cross-cutting legislative development including the Biotech Act and other cross-sector initiatives

Profile
The successful candidate:

• Must have full permission to work in Belgium;
• Graduated in EU affairs and/or public health, science, regulatory affairs, political sciences, law or other area relevant to Healthcare Biotechnology;
• Must be a strong communicator and team player, able to work with Europa Bio teams to deliver high profile activities.
• Should have interest and experience with regulatory framework for medicines in Europe and preferable with experience working from an industry perspective, either directly or indirectly
• Proven practical knowledge of European and/or national policymaking, acquired during at least 1-2 years working experience in European Institutions and/or in a company, industry associations, or in consultancy firms, preferably with direct contact to European institutions and/or EU stakeholder;
• Will suit somebody interested in contributing to association development and activities across members and Europa Bio Councils
• Should have a desire to grow through working with the Europa Bio team to propose and help lead activities and representing the Association to potential Members
• Fluent written and spoken English (working language); additional EU languages a plus; Must have a very high standard of both written and spoken English (office language);
• Should be able to begin as soon as possible.

Our commitment to you

• Support for professional career development
• An engaging position, in a Healthcare team of 4 people, within a growing Europa Bio team of 12+ people
• Exposure to a fast growing industry at the centre of Europe’s transformation, and a key enabling technology for future medical and environmental innovation;
• Motivated colleagues and expert membership at the top of their field who readily impart knowledge and who work across teams;
• A comfortable central Brussels office space (combines closed and open plan) with an excellent view and an abundant supply of coffee and the occasional cake;
• Structured teleworking, combining home and office-based working;
• Generous benefits (see below)

Terms and conditions
At Europa Bio we value Work-life-balance. Staff well-being is of the utmost importance to us and we provide a great deal of flexibility to members of staff.
You will be offered a full time open-ended position (CDI), 40 hours/week.
Working hours are from 09:00 until 18:00 Monday – Friday.
In addition to 20 legal holidays, 12 RTT days and end-of-year closing.
Hospital, travel and group insurance.
Salary is 2700€ gross/month.
Meal vouchers of 8€/day worked;
Public transport costs;
Possibility to telework 2 days/week
Teleworking stipend.
How to apply
To apply, please send a CV and a cover letter to Majken Ekam-Nielsen, People, Culture & Finance Director m.ekam-nielsen@europabio.org with the subject “Regulatory affairs” by December 25th 2024.

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