Director, European Regulatory
About the Alliance for Regenerative Medicine
The Alliance for Regenerative Medicine (ARM) is the leading international
advocacy organisation dedicated to realizing the promise of advanced therapy
medicinal products (ATMPs). ARM promotes legislative, regulatory and
reimbursement initiatives in Europe and internationally to advance this
innovative and transformative sector, which includes cell therapies, gene
therapies and tissue-based therapies. Early products to market have
demonstrated profound, durable and potentially curative benefits that are
already helping thousands of patients worldwide, many of whom have no other
viable treatment options. Hundreds of additional product candidates contribute
to a robust pipeline of potentially life-changing ATMPs. In its 11-year
history, ARM has become the global voice of the sector, representing the
interests of 370+ members worldwide and 70+ members across 15
European countries, including small and large companies, academic research
institutions, major medical centres and patient groups.
Director, European Regulatory – this is an exciting opportunity for a
consultant to step into this role, evolving ARM’s regulatory strategy consistent
with its policy, political and advocacy goals in Europe.
Based on experience. Position is approx. 30 hours per week, with some
intra-European travel required along with occasional travel to the U.S.
Preference for position to be based in Brussels, Belgium, but will consider
qualified candidates in other European countries.
The Director, European Regulatory will report to the Senior Vice President of
Global Public Affairs and collaborate with her to develop, drive and execute
ARM’s regulatory affairs strategy in Europe. This role will lead the European
Regulatory Affairs Committee and work closely with European and US
• Advance ARM’s regulatory policy positions among key European
stakeholders, including the European Commission, The European
Medicines Agency and the EMA’s Committee for Advanced
Therapies, among others.
• Reinforce ARM as the global – and European – voice of the cell &
gene therapy sector, ensuring stakeholders reach out to ARM for all
regulatory-related guidance and inquiries in the ATMP sector.
• Actively and strategically manage ARM’s European Regulatory
Affairs Committee, including: lead ARM’s response to public
consultations that focus on ATMPs, draft/edit position papers,
partner with Committee co-chairs on goal achievement and
meeting agendas, and regularly interact with members.
• Engage with the European Medicines Agency and its relevant
committees, as well as country-specific regulatory bodies to
support and advance ARM’s regulatory policy positions.
• Partner with US Regulatory counterpart as well as the European
Directors of Public Affairs and Market Access & Value, and the
Director of Public Affairs (global media) to ensure the consistent
execution of ARM’s integrated European public affairs strategy.
• Prep SVP Global Public Affairs, ARM CEO and colleagues in
advance of regulatory meetings with key European
• Join Director of European Government Relations & Advocacy, as
needed, at policymaker meetings to advance regulatory policy.
• Draft policy positions and papers, briefing documents, reports, etc.
SKILLS & EXPERIENCE:
• 15+ years’ experience as an effective Brussels-focused healthcare
and/or biotech regulatory specialist. Previous in-house, corporate
experience is a strong plus.
• Must have 5+ years’ experience in public affairs and/or government
relations, having executed integrated pan-European strategic public
• Demonstrated ability to strategically assess developing regulatory
opportunities and risks and counsel ARM colleagues in real-time.
• Adept at translating complex healthcare terminology into easily
understandable information for policymakers.
• Demonstrated experience effectively engaging with relevant
European regulatory stakeholders in Brussels, at the pan-European
and individual country levels.
• Ability/desire to regularly work early evening hours to collaborate
with US colleagues.
• Experience working for a US-based corporation or organization is a
• Seeking energetic, go-getter – accomplished in seeing around
corners & making things happen. Team player who lives and
• Exhibits calm under pressure and when working against deadlines.
• Demonstrates highly professional demeanor and excellent interpersonal skills; experienced working with policymakers.
• Experience partnering with external vendors, including public
• Fluency in English required. Fluency in German or French a plus.
• Exceptional written and verbal communication skills.
• BS/BA required; MS/MA/MBA preferred.
Interested applicants should send a resume and cover letter to: Rashida
Dujue-Jackson @ firstname.lastname@example.org
Job posted: 2021-10-13