Director Regulatory Affairs

Director Regulatory Affairs, EFPIA

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.

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 [email protected].
• 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