Vacancy: Manager, Scientific, Regulatory & Manufacturing team
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.
The Manager Scientific, Regulatory & Manufacturing – ICH (SRM-ICH) coordinates and leads the work on allocated topics and tasks related to scientific, regulatory and manufacturing, more specifically focussed on representing EFPIA towards the International Council on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH), 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 in relation to scientific, regulatory and manufacturing topics and as ICH coordinator he/she is the main contact point towards ICH Secretariat, ensuring smooth communication between ICH Management and – Assembly and ICH Working groups.
The Manager SRM-ICH reports to the SRM Team Leader.
- Coordinate and support EFPIA’s work as founding member of ICH in global harmonisation of regulatory requirements;
- Ensure and coordinate EFPIA’s timely response to requests from ICH Secretariat regarding among others draft guidelines, communication plans, training strategies, financial documents, minutes from Management Committee (MC) and Assembly meetings;
- Lead work on the appointment of EFPIA experts in ICH expert working groups (WG) in close collaboration with chairs/vice chairs of relevant EFPIA expert working groups and EFPIA members of the ICH MC;
- Identify issues in ICH expert WGs and advise our experts on how to resolve them.
- Lead EFPIA work regarding the identification and prioritisation of new/revised ICH topics and reflection papers and the corresponding EFPIA response;
- Act as alternate for members of ICH MC and –Assembly in meetings, when required;
- Report to relevant EFPIA WGs on ICH developments;
- Represent EFPIA at ICH Coordinator´s meetings and subcommittees;
- Regulatory support to any other assigned committee with the focus on international dimension, such as the International regulatory expert working group, virtual regulatory country/regional networks and International Board Sponsored Committee;
- Representing EFPIA at relevant external meetings/events.
- 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;
- 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 ICH and working with the regulatory agencies world-wide;
- Knowledge and familiarity of collaboration with other relevant life sciences stakeholder groups.
- Knowledge of other European languages is an asset.
- 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 even with limited information, manage diverging opinions and reach consensus;
- Strong team player with good interpersonal skills;
- Ability to adapt to constantly evolving external and internal environment.
- A permanent contract covering a full time position
- Interested candidates should send their application by 31 January 2018, or address any question on the position to firstname.lastname@example.org. The application should consist of:
- Cover letter max. half page