Manager, Advocacy and Regulatory Policy

PPTA - Plasma Protein Therapeutics Association

Manager, Advocacy and Regulatory Policy

PPTA - Plasma Protein Therapeutics Association

Brussels, Belgium

About PPTA

The Plasma Protein Therapeutics Association (PPTA) is the global industry trade association representing the private sector collectors of source plasma (plasma for manufacturing) and manufacturers of plasma-derived medicinal products (PDMPs). PPTA drives broad and reliable access to plasma derived medicinal products with a focus on the well-being of patients and plasma donors. These therapies are used by small patient populations worldwide to treat a variety of rare diseases and serious medical conditions.

PPTA Europe (located in Brussels) is actively engaged in setting advocacy and priority initiatives and strategies for improving access to care to PDMPs at the level of the European Union level and within individual EU member states. Staff is engaged in shaping the legislative, policy, regulatory and trade environment.

Position summary

The manager will be a key team player working in a matrix with other PPTA senior staff to manage the regulatory and trade policy activities primarily in Europe. The manager will be responsible for evaluating, reporting on, and advocating on behalf of regulatory policy initiatives. The manager will support advocacy activities with regulatory and policy agencies and peer groups. These activities include monitoring, evaluating, and contributing to legislative and regulatory policy initiatives related to blood/plasma products industry and working with PPTA committees to develop consensus positions and guidelines to shape decisions of a range of stakeholders to improve availability of PDMPs.

Major activities

The Manager, Advocacy and Regulatory Policy, Europe, will be responsible for:

  • Supporting the development of the organisation’s advocacy activities in Brussels in the areas of regulatory and trade policy under the supervision of the Executive Director, in collaboration with the Senior Director Regulatory Affairs and in coordination with Health Policy colleagues;
  • Shaping EU legislation, policy, and regulatory environment by identifying issues impacting industry regulatory policy and developing strategies for addressing the issues (Key dossiers: EU Pharma legislation, EU Orphan and Paediatric legislation, EU-third countries’ trade/mutual recognition agreements for pharmaceuticals and the EU Blood Directive).

Duties and responsibilities

  • Draft and manage position papers, recommendations and industry consensus positions on regulatory and trade policies affecting the industry;
  • Assist in the development of standards and guidelines of a regulatory nature;
  • Define and develop proactive proposals, external advocacy, and strategic initiatives to foster a beneficial regulatory environment through interaction with:
    • European Commission;
    • European Medicines Agency;
    • European Directorate for Quality of Medicines (EDQM);
    • National Competent Authorities within EU and Rest of the World, as needed;
    • Members of the European Parliament and EP staff;
    • Relevant Attaches of Permanent Representations to the EU;
    • Other industry organisations and stakeholders.
  • Coordinate external advocacy, with internal teams and members, on specific policy dossiers and legislative proposals - focusing on the European Parliament, Council, Commission, European Medicines Agency, and other external stakeholders;
  • Organise and assist with external events with the aim to educate and inform as well as foster existing relationships and build new ones with key stakeholders and opinion leaders;
  • Support the organisation in internal meetings and work in an international matrix organisation.

Requirements

Qualifications:

  • University degree (Bachelor of Arts/Science/Business/Law).
  • Advanced degree in public health, public policy, international affairs, political science, law is an advantage;
  • Alternative combinations of education and experience will be considered.

Experience:

  • 5+ years of direct experience in European policy and government affairs – an understanding of the external environment, the EU political and legislative decision-making processes, and regulatory and trade policy is a must;
  • Experience with European Medicines Agency’s National Competent Authority(ies) regulated industry (heath/medicinal products), and/or industry association and/or legal firm is an advantage;
  • Alternative combinations of education and experience will be considered.

Skills:

  • Excellent written and verbal communication skills in English, good command of other European language(s) is an asset;
  • Team player with excellent interpersonal skills, including networking and collaboration in an international setting and ability to build relationships of trust with a wide range of individuals and organisations;
  • Excellent influencing skills, persuasiveness, and sense of diplomacy;
  • Ability to multi-task, manage projects, handle complex issues, and translate these into sound analysis and strategy;
  • Ability to grasp complex technical information and translate it for non-expert audiences;
  • Ability to function as part of a team and work within a matrix reporting scheme, while also able to work independently;
  • High personal accountability and integrity;
  • Willingness to travel, availability for occasional work outside regular office hours;
  • Having an existing relevant network is an asset.

The ideal candidate will show considerable commitment to the work and demonstrate enthusiasm and a positive attitude towards the various projects assigned and towards colleagues and members.

What we offer

  • Dynamic, multicultural working environment;
  • A full time, indefinite contract;
  • Attractive salary package with comprehensive benefits;
  • Annual performance bonus and pension scheme.

How to Apply

Interested candidates are requested to submit their application by attachment to an e-mail to cizzi@pptaglobal.org, to the attention of Cathy Izzi.

The application must include a CV and a cover letter outlining the motivation for this position at PPTA.

Applications will be accepted through 15 August 2021.

The interviews for the position will take place in Brussels or online. In case of questions, please do not hesitate to send an e-mail to cizzi@pptaglobal.org.

Don't forget to mention EuroBrussels when applying.

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© EuroJobsites 2021

EuroJobsites is a registered company number: 4694396 VAT number: GB 880 9055 04

Registered address: EuroJobsites Ltd, Unit 8, Kingsmill Business Park, Kingston Upon Thames, London, KT1 3GZ, United Kingdom

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