The European Federation of Pharmaceutical Industries and Associations (EFPIA) represents the pharmaceutical industry operating in Europe. Through its direct membership of 36 national associations and 39 leading pharmaceutical companies and in collaboration with health and research players, EFPIA's mission is to create an 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 and responsibilities:
The regulatory landscape in Europe for medicines and medical products is rapidly evolving with a trend to greater complexity. This reflects scientific developments as well as political and budgetary pressures.
EFPIA wants to strengthen its legal capacity and is looking for a Manager Regulatory Law and Policy who will ensure that EFPIA's regulatory policy work focuses on delivering on our priorities. You will be responsible for interpreting, advising and communicating about European regulatory requirements and systems. Within EFPIA’s Legal Team you will develop and coordinate EFPIA’s regulatory law strategy.
Within the Legal Team you will lead on regulatory matters, while working closely with a number of other EFPIA teams covering Regulatory, Scientific, Trade, Economic & Social Affairs, Government Affairs and Communications issues. You will also work closely with EFPIA’s membership, as well as external experts and stakeholders. You will aim to identify at an early stage, key areas for action and designing/recommending industry response and engagement. You will advise on all regulatory aspects of the medicinal product lifecycle, marketing authorisation, procedures and disputes, clinical trials, manufacturing, repurposing, unauthorized use for economic reasons and parallel trade.
- Establish objectives, operational plans and performance indicators for EFPIA’s regulatory strategy
- Coordinate and drive the work of relevant EFPIA working groups, as well as to other EFPIA teams with regard to regulation and legal issues;
- Follow EU developments and opportunities, and formulate recommendations for EFPIA working groups ;
- Draft advocacy material and internal advice on a broad range of regulatory law and policy issues;
- Advocate EFPIA policy positions with key institutional stakeholders;
- Represent EFPIA at relevant external events and meetings, presenting on relevant regulatory law and policy issues.
- EU Citizen
- Master's Law Degree, with a good knowledge of EU, Pharmaceutical and Competition Law;
- 7-10 years of experience in the pharmaceutical/healthcare/life sciences industry;
- Fluency in English (native speaker or equivalent) with proven capacity to draft policy positions and legal advice, as well as strong communication and advocacy skills;
- Good IT skills, familiarity with common office software package and with social media.
The following would be assets:
- Good knowledge of the pharmaceutical industry / healthcare sector;
- Experience of the functioning of European institutions and EU decision-making process;
- Established networks in regulatory policy and in Brussels;
- Experience in working in a law firm, trade association or pharmaceutical company;
- Experience in managing and leading working groups and projects.
- Excellent analytical, attention to detail, communication (written and spoken) and organisational skills and a strong team-oriented approach;
- Highly flexible, comfortable with managing multiple projects in a dynamic environment – sometimes against short deadlines, combined with an ability to adapt to constantly evolving external and internal environments;
- Self-starter, capable of developing innovative and original insights and analysis;
- Strong people, networking and collaboration skills with a track record of dealing with people at all levels of your organization.
- A permanent contract with an ideal start date no later than 1 October 2019.
- Interested candidates should send their application by 8 September 2019 to email@example.com
- The application should consist of:
- Cover letter max. half page
- A 1-pager outlining the 3 main regulatory law challenges for the pharmaceutical industry.
Given the size of our team and the time constraints, we will not be able to take into account applications that do not meet the essential requirements above and the page limits for the CV and cover letter. We are grateful for your understanding and your interest in EFPIA.