Director Regulatory Affairs
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.
- 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
- 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
- Strong communication and inter-personal skills
- 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
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 firstname.lastname@example.org.
The application should consist of:
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
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.