Regulatory Affairs Manager/Senior Manager

Biotechnology is at the forefront of transformative, cutting-edge and research-intensive scientific advancement. Enabling wide-scale societal change, biotechnology underpins technology to address unmet medical needs and provide sustainable, resource-efficient, climate-friendly products and processes.

EuropaBio, the voice of Europe’s dynamic biotechnology industry, is currently seeking a motivated Regulatory Affairs Manager to join the Healthcare Biotechnology Team for an indefinite period.

EuropaBio 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 develop and lead Regulatory Affairs initiatives in EuropaBio, as primary point of contact for members and stakeholders, with a strong focus on career development within an association.

The role includes:
• Grow EuropaBio activities within the field of 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.
• Promote regulatory interventions from EuropaBio to the European Commission, European Parliament and other relevant stakeholders; plus initiatives where EuropaBio is involved such as the Innovative Medicines Initiative
• Support regulatory aspects of other EuropaBio Working Groups including ATMPs and OMPs plus the National Associations Council
• Work closely alongside Public Affairs colleague(s) to create a complete service for impactful advocacy for biotechnology, including development of position papers and supporting external communications.
• Contribute to the development of long term EuropaBio strategy for healthcare advocacy and translation of regulatory priorities into impactful activities,
• Support association administration, including the management and development of junior staff, and budget development and oversight

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;
• Should have interest and experience within 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 public affairs, advocacy and communications, acquired during at least 2 years working experience in industry, industry associations, in-house public affairs/corporate affairs departments or in public affairs consultancy firms, preferably with direct contact to European institutions;
• Will suit somebody interested in developing association strategy and activities across members and EuropaBio Councils
• Would like to take the opportunity to lead EuropaBio’s external representation for regulatory activities, together with members
• Should have a desire to grow into a senior role through working with the EuropaBio team to propose and help lead activities and representing the Association to potential Members
• Must be a strong communicator and team player, able to work with EuropaBio teams to deliver high profile activities.
• 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 (and by early February 2023 at the latest).

Our commitment to you
• Support for professional career development
• An engaging position, in a Healthcare team of 4 people, within a growing EuropaBio team of 12+ people
• Exposure to a fast growing industry at the centre of Europe’s digital and green 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
An open-ended contract (CDI), 40 hours/week
In addition to 20 legal holidays, 12 RTT days and end-of-year closing
Hospital, travel and group insurance
Meal vouchers
Public transport costs
Possibility to telework 2 days/week

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 January 6th 2023.