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EFPIA vacancy: Manager, Scientific, Regulatory & Manufacturing Affairs

About EFPIA:

The European Federation of Pharmaceutical Industries and Associations (EFPIA) represents the pharmaceutical industry operating in Europe. Through its direct membership of 33 national associations and 40 leading pharmaceutical companies, EFPIA is the voice on the EU scene of 1,900 companies committed to researching, developing and bringing to patients new medicines that will improve health and the quality of life around the world.

Role:

The Manager Scientific, Regulatory & Manufacturing Affairs (SRM) coordinates and leads the work of allocated topics and tasks related to scientific, regulatory and manufacturing topics. He/she provides regulatory support to other teams. He/she also represents EFPIA towards the European Medicines Agency, national Medicines Regulators and the European Commission.

Within the Scientific, Regulatory & Manufacturing team, he/she provides expertise and performs tasks related to legislative and policy issues on scientific, regulatory and manufacturing topics. He/she independently leads multiple projects and coordinates the work of relevant working groups.

The Manager SRM reports to the SRM Team Leader.

Responsibilities include:

  • Coordinate and drive multiple working groups representing experts from EFPIA member companies and associations;
  • Support the Clinical Development Expert Working Group (CDEG), Technical Development Expert Working Group (TDEG), Supply Chain Priority Working Group (SCWG) and national trade association regulatory network (NtA Reg Network);
  • Support to Innovation Board Sponsored Committee and Paediatrics Priority Working Group on regulatory topics;
  • Provide Regulatory Affairs input to cross-functional groups internally/externally;
  • Lead response preparation on multiple internal/external questions;
  • Oversee the EFPIA response to scientific guidelines and consultations in order to ensure it represents a balanced view from membership;
  • Track and communicate key regulations and policy changes and identify strategies and next steps with the support of EFPIA priority or expert working groups;
  • Represent EFPIA at relevant external meetings/events.

Minimum qualifications:

  • Masters Degree in Pharmaceutical Sciences or equivalent scientific degree (biology, chemistry);
  • At least 5 years of experience in pharmaceutical industry, drug regulatory authority or industry trade association / healthcare policy work;
  • Professional fluency in English; knowledge of other European languages is an asset;
  • Good knowledge of MS Office software package.

The following would be assets:

  • Experience in drafting position papers/memos, leading cross-functional teams and holding public presentations;
  • Familiarity with the functioning of the European institutions;
  • Knowledge and familiarity of collaboration with other relevant life sciences stakeholder groups.

Skills:

  • Strong organisational and project management skills; ability to manage multiple tasks under pressure and respect deadlines;
  • Attention to detail with ability to see the big picture
  • Self-motivated, dynamic and decisive
  • Ability to independently lead and coordinate teams and projects, manage diverging opinions and reach consensus;
  • Strong team player with good interpersonal skills;
  • Ability to adapt to a constantly evolving external and internal environment

EFPIA offers:

  • A permanent contract covering a full time position;
  • Interested candidates should send their application by 22 August 2017, or address any question on the position to vacancy@efpia.eu. The application should consist of:
    • CV
    • Cover letter max. half page
    • A one-pager outlining the three most important strategic regulatory topics for the future and why you think they are important.