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Director Regulatory Affairs
 
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.