Regulatory Policy Manager (Manufacturing Operations)

Company details

Do you want to play an important role in ensuring access to off-patent medicines in Europe and more specifically in the development of Manufacturing Operations and Regulatory Policies?

Are you familiar with the pharmaceutical sector?

Are Medicines for Europe’s five pillars: Patients • Quality • Value • Sustainability • Partnership also your values?

If so, you might be our next Regulatory Policy Manager.

Why work for Medicines for Europe?

  • Since 1993, Medicines for Europe has represented pharmaceutical companies supplying the largest share of prescription medicines across Europe.
  • They are 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.

Function

Your key responsibilities

The Regulatory Policy Manager will:

  • Develop and lead Policy and Regulatory Operations Strategy in the following areas: Manufacturing and supply chain, Digitalisation, Environmental and Green policies, and Quality.
  • Oversee - in close collaboration with 2 direct reports - the different projects of the Manufacturing and Supply chain Committee as well as of the various workstreams and groups related to the above areas. The activities will include:
    • Monitor, analyse, and advise on the relevant key policy, regulatory and scientific areas.
    • Research and monitor policy developments and key topics, including regulatory and science.
    • Coordinate the corresponding Committees, working groups and task forces, including drafting agenda, minutes, reports and briefing notes.
    • Liaise and maintain active collaboration with partner European Trade associations (i.e. EFPIA, AESGP, EFCG, APIC etc.) and other stakeholders on common policy issues on behalf of Medicines for Europe.
    • Advocate on these issues on behalf of Medicines for Europe to the relevant decision makers and other stakeholders such as the European Commission, National Competent Authorities, EMA QWP, EMA Inspectors WP, EDQM, WHO, PIC/S and others.
    • Liaise with and provide support to other Medicines for Europe Sector Groups, Committees and Working Groups on horizontal issues.
    • Inform and engage with the Executive and Board on the issues indicated above, as appropriate.
    • Represent the association in various meeting and conferences.
  • Support the organisation of events (incl. programme development) of a range of advocacy and outreach events (including individual sessions and workshops).
  • Draw up the response to public consultations (e.g. draft legislations, guidelines), develop position papers, develop and conduct surveys amongst the different working groups and inform association members of developments in the areas indicated above.
  • Contribute to the development of communication and educational materials as needed.

Profile

  • A Master’s degree in EU policy/law or in related scientific domain.
  • Minimum 2 years’ experience in European health/pharmaceutical policy, European pharmaceutical industry or EU environmental policy.
  • Proficiency in English (written and spoken).
  • Excellent project management skills including ability to handle multiple parallel projects and flexibility to adapt and reprioritise time sensitive issues.
  • Strong communicator, with good writing and presentation skills, ability to simplify complex or technical matters.
  • Experience in advocating towards decision makers would be an asset.
  • Dynamic, entrepreneurial (proactive & autonomous) and with a “can-do” mentality.
  • Comfortable working in a multi-cultural, international environment.
  • Proficiency in Microsoft Office applications such as Word, PowerPoint, Excel, and similar software.

Offer

  • Competitive Salary + Meal vouchers (8€), Net remote work allowance, Hospitalisation insurance and Pension fund.
  • Up to 2 days teleworking/week.
  • The possibility to represent a dynamic European industry and interact with diverse stakeholders.
  • The opportunity to take ownership and have impact as well as being part of a motivated and multicultural team.

Hiring process

  • 1st and 2nd interview with the Director General, Deputy Director General and Head of Human Resources.
  • Decision after 10 working days.

We are looking forward to receiving your cv.

Please upload your cv via the Apply Now Button

Placed on:Mon 5 December 2022
Location: Brussels

Interested?

For more information:
Call EMMA WAITES
at the number: 02 738 02 63 GSM 0475 614967
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