About the Role
Medicines for Europe represents the generic, biosimilar, and value-added medicines industry across Europe, advocating for sustainable access to medicines for all patients.
The Associate Director leads Medicines for Europe’s policy and advocacy activities across two strategic portfolios:
- Biosimilar Medicines Group coordination and Biosimilar Policy, including scientific, regulatory, market access and industrial policy; and
- Manufacturing, Supply Chain & Industrial Policy, including (bio)pharmaceutical manufacturing, medicine shortages, resilience, critical medicines, industrial competitiveness and related EU legislative initiatives.
The Associate Director will represent Medicines for Europe and the Biosimilar medicines group externally in meetings with political, regulatory, industry and public health stakeholders.
The Associate Director manages two direct reports:
- Biosimilar Regulatory & Science Lead
- Manufacturing, Supply Chain & Industrial Policy Lead
The position also requires strategic vision, policy development, stakeholder management and people leadership to ensure Medicines for Europe remains the leading voice of the off-patent medicines industry in Europe and the global centre of excellence for Biosimilar medicines policy.
Key Responsibilities
Strategic Leadership
- Develop and implement the association’s policy strategy across biosimilar medicines and manufacturing, supply chain and industrial policy.
- Gather intelligence, identify, anticipate and assess emerging European (and international) legislative, regulatory, scientific and political developments affecting the off-patent medicines sector.
- Translate complex policy developments into strategic priorities and advocacy objectives for the association.
- Engage in external outreach to Institutional and non-institutional stakeholders that contribute to a successful biosimilar medicines policy in Europe.
- Advise the Director General and DDG on strategic policy developments, and emerging risks and opportunities.
Biosimilar Medicines Policy
- Manage the Biosimilar medicines sector group membership and coordinate activities.
- Oversee the Biosimilar medicines sector group’s work across the full biosimilar policy landscape, including:
- Strategic oversight of the sector and effective governance and delivery of objectives and priorities.
- Scientific and regulatory policy, incl. quality, clinical and non-clinical requirements, pharmacovigilance, regulatory science, procedures.
- Market and access policies for biosimilar medicines.
- Overseeing the Biosimilar Regulatory & Science Lead, the Associate Director will:
- Oversee development of policy positions, consultation responses and technical guidance.
- Coordinate the Biosimilar Medicines Group, Steering Group and oversee associated task forces.
- Actively shape and support implementation of advocacy strategies that promote timely patient access to biosimilar medicines / European biosimilar competitiveness.
- Lead the Biosimilar medicines conference (programme, speaker, side-meetings, communication) and support other conference programmes, workshops and policy events.
Manufacturing, Supply Chain & Industrial Policy
- Provide strategic vision across manufacturing and industrial policy, including:
- Supply chain resilience and preparedness (incl. medicines shortages).
- Strategic autonomy and competitiveness.
- European industrial policy including Critical Medicines Act implementation, Biotech initiatives and Pharmaceutical legislation (relevant provisions).
- Development/manufacturing investment and EU funding.
- Antimicrobial Resistance.
- Anti-Counterfeiting, Serialisation and EMVO related topics.
- Overseeing the Manufacturing, Supply Chain & Industrial Policy Lead, the Associate Director will:
- Guide policy development and advocacy priorities.
- Oversee the Manufacturing & Supply Chain Committee, Biotech Act TF, Anticounterfeiting WG, AMR coordination group.
- Lead policy responses to legislative and regulatory initiatives affecting pharmaceutical industrial footprint (development manufacturing).
- Drive Medicines for Europe’s contribution to industrial policy discussions across Europe.
External Representation
- Build consensus across diverse stakeholder groups while advancing the interests of Medicines for Europe and Biosimilar medicines group members, particularly with:
- Member associations and companies’ expert representatives.
- European Medicines Agency and national competent authorities
- European and international trade associations
- Patient and Healthcare professional organisations.
- Academic experts’ consultancies and service providers.
- World Health Organization.
- European Institutions.
Ideal Candidate Profile
Qualifications & Experience
- Master’s degree (or equivalent) in Pharmacy, Life Sciences, Public Health, Economics or another relevant discipline.
- Passion for public health and improving access to medicines.
- Approximately 8 years or more of progressively responsible experience in European pharmaceutical policy regulatory affairs or related fields.
- Strong knowledge of the European pharmaceutical policy landscape, particularly relating to generic and biosimilar medicines.
- Demonstrated experience leading complex policy and advocacy programmes.
- Experience managing multidisciplinary teams and developing high-performing staff.
- Strong understanding of European regulatory systems, pharmaceutical legislation and industrial policy.
- Proven experience engaging with European institutions, regulators and international organisations.
- Experience representing organisations externally and influencing senior decision makers.
Skills & Competencies
- Strategic leadership and organisational awareness.
- Excellent policy analysis and political judgement.
- Strong understanding of pharmaceutical regulation, manufacturing and market access.
- Outstanding written and verbal communication skills.
- Exceptional drafting skills for policy and advocacy documents.
- Strong stakeholder management and consensus-building abilities.
- Excellent facilitation, negotiation and influencing skills.
- Proven ability to manage multiple complex projects simultaneously.
- Strong people management and coaching capabilities.
- Entrepreneurial, proactive and solutions-oriented mindset.
- Ability to simplify complex scientific, regulatory and policy issues for different audiences.
- Comfortable operating in an international, multicultural environment.
Languages
- Excellent written and spoken English.
- Additional European languages are considered an advantage.
Why work for Medicines for Europe:
- Since 1993, Medicines for Europe has represented pharmaceutical companies supplying the largest share of prescription medicines across Europe.
- The association is the voice of the generic, biosimilar and value-added medicines industries.
- Leading partner for political change at an EU level and hence better healthcare.
- Increasing the health and wellbeing of all Europeans through better access to high quality medicines.
- The portfolios of Medicines for Europe members cover 80% of therapy areas.
- Safeguarding the sustainability of Europe’s healthcare systems for future generations.
