Director Regulatory Affairs

EFPIA - European Federation of Pharmaceutical Industries and Associations

Director Regulatory Affairs

EFPIA - European Federation of Pharmaceutical Industries and Associations

Brussels, Belgium

Role:

The Director Regulatory Affairs reports to the Director Regulatory, Drug development and Manufacturing. He/she coordinates monitoring, development, and implementation of EFPIA’s regulatory strategies, with a particular focus on paediatric legislation (policy, legislation, alliance building), and other regulatory strategic projects as needed. The successful candidate also works on enhancing international convergence through ICH. He/she supports high level EFPIA interactions with European/International regulatory agencies and European Institutions on regulatory affairs matters.

Key Responsibilities:

  • Develop and implement regulatory strategies;
  • Secretariat support to relevant expert groups;
  • Track and communicate key regulatory and policy changes as well as identify strategies and next steps with help from EFPIA expert working groups;
  • Strategic support to ICH Management Board members, coordination of activities related to global regulatory convergence through ICH and support to the International Regulatory Affairs Expert Group;
  • Regulatory Affairs input to cross-functional groups internally/externally;
  • Coordinate the preparation of the EFPIA response to scientific guidelines and consultations;
  • Represent EFPIA at relevant external meetings/events.

Minimum qualifications:

  • Masters Degree in Pharmaceutical Sciences or equivalent scientific degree (biology, chemistry);
  • At least 10-year experience in the pharmaceutical industry, drug regulatory authority or industry trade association, of which 5 years in a regulatory affairs or regulatory policy and intelligence position;
  • Familiarity with the functioning of the European institutions;
  • Experience in drafting position papers/memos, leading cross-functional teams and giving public presentations;
  • Professional fluency in English;
  • Relevant computer literacy skills.

The following would be assets:

  • Previous experience in Health Authority interactions (EMA, FDA, JPMA and/or national);
  • Knowledge and familiarity of collaboration with other relevant life sciences stakeholder groups.

Skills:

  • Strong communication and inter-personal skills;
  • Diplomacy;
  • Strong organisation and project management skills;
  • Attention to detail with ability to see the big picture;
  • Self-motivated and dynamic;
  • Ability to independently lead and coordinate teams and projects;
  • Strong team player;
  • Ability to represent diverse opinions of a group and reach consensus;
  • Ability to adapt to rapidly evolving external and internal environment.

EFPIA offers:

  • A permanent contract to start as soon as possible;
  • Interested candidates should send their application by August 8, 2021, or address any question on the position to vacancy@efpia.eu;
  • The application should consist of:
    • CV;
    • Cover letter max. half page;
    • A 1-pager outlining the the strengths and limitations of the EU pharmaceutical regulatory framework from the perspective of innovators.

About EFPIA:

The European Federation of Pharmaceutical Industries and Associations (EFPIA) represents the biopharmaceutical industry operating in Europe. Through its direct membership of 36 national associations, 39 leading pharmaceutical companies and a growing number of small and medium-sized enterprises (SMEs), EFPIA’s mission is to create a collaborative environment that enables our members to innovate, discover, develop and deliver new therapies and vaccines for people across Europe, as well as contribute to the European economy.

Due to a high volume of applications received, we are unable to contact each applicant individually regarding the status of their application.

Don't forget to mention EuroPharmaJobs 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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