Manager, Lead for Regulatory Affairs Europe - Brussels, België - Plasma Protein Therapeutics Association

Beschrijving

The Manager, Lead for Regulatory Affairs, Europe, will be a key team player working in a matrix with other PPTA staff to manage the regulatory and scientific affairs activities primarily in Europe.

The manager will be responsible for evaluating and reporting on industry issues of a regulatory and scientific nature.

This includes monitoring, evaluating, and contributing to legislative, regulatory, quality and safety initiatives related to plasma therapeutics industry, through working with PPTA's members to develop consensus positions and guidelines to shape decisions of a range of stakeholders to improve the regulatory environment and, ultimately, the availability of PDMPs in Europe.

The manager will maintain active collaboration with partner industry trade associations on issues of joint interest.


Key activities:

• Support the development of the organisation's regulatory and scientific activities in Brussels, under the supervision of the Senior Director, Head of Global Regulatory Policy.
• Shape EU regulatory environment by identifying issues impacting industry regulatory provisions and help to develop strategies for addressing the issues (Key files: EU SoHO Regulation, EU Pharma legislation, Variations Regulation).
• Oversee, assess, and respond to regulatory developments in Third Countries/ Rest of the World region related to the plasma products industry.

Duties and responsibilities:

• Draft and manage responses to position papers, as well as provide input on standards, guidelines, recommendations, and industry consensus positions on regulatory requirements for collection of plasma, manufacturing and supply chain and quality/ safety of PDMPs.
• Define and develop proactive proposals, external advocacy and provide input into strategic initiatives to foster a beneficial regulatory environment through interaction with organizations such as: European Medicines Agency (EMA); European Directorate for Quality of Medicines (EDQM); National Competent Authorities within EU and Rest of the World, as needed; PIC/S; WHO.
• Organise and assist with external stakeholder events with the aim to educate and inform as well as foster existing relationships & build new ones with key regulatory and scientific decisionmakers and influencers.
• Provide active support to other PPTA groups on horizontal/crosscutting issues in Europe and in the U.S., as required, including contributing to the development of communication and education materials.
• Support the organization in internal meetings and work in an international matrix organization.

Requirements:


Qualifications:

• University degree (Bachelor in Science/Public Health).
• 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:

• Minimum of 2 years of experience in roles interacting with the European Medicines Agency/National Competent Authority(ies) (EMA/NCA)regulated industry (heath/ medicinal products) or/ and industry association/ legal firm.
• Advanced degree or experience in public health/ public policy/ and understanding the external environment, EU legislative and national member state regulatory decisionmaking processes would be beneficial.
• Experience in advocating towards healthcare/ scientific decision makers would be an asset.
• Alternative combinations of education and experience will be considered.

Skills:

• Excellent written and verbal communication skills English, good command of another European language(s) is an asset;
• Excellent interpersonal skills, including networking and collaboration in an international setting ability to build relationships of trust with a wide range of stakeholders;
• Ability to grasp complex technical information and "translate" and simplify it for nonexpert audiences; and translate it into sound analysis and strategy;
• Ability to multitask, project manage and handle multiple complex issues at the same time, and flexibility to adapt and reprioritize timesensitive matters;
• Ability to function as part of a team and work within a matrix reporting scheme, while also able to work independently, if needed;
• High personal accountability and integrity, with a dynamic "can do" attitude.

How to apply
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