About EFPIA:
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, 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. Our vision is for a healthier future for Europe. A future based on prevention, innovation, access to new treatments and better outcomes for patients.
Role:
The legal and regulatory landscape in Europe for medicines and medical products is rapidly evolving with a trend to greater complexity and increasing scrutiny and enforcement. This reflects not only scientific developments, but also political and budgetary pressures.
EFPIA wants to help shape a legal and regulatory environment that supports innovation and ensures patients can access the healthcare and medicines they need. As Legal Manager you will be responsible for interpreting, advising and communicating about a broad range of European legal and regulatory requirements and systems. Within EFPIA’s Legal Team you will develop and coordinate EFPIA’s legal and regulatory law strategy working closely with colleagues in the Legal team and a number of other EFPIA teams covering Regulatory, Scientific, Trade, Economic & Social Affairs, Government Affairs, Health Systems and Communications. 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 report to EFPIA’s General Counsel.
Responsibilities include:
- Advise on all legal and regulatory aspects of the medicinal product lifecycle including R&D incentives, generics, biosimilars, orphan and pediatrics medicines, marketing authorization, procedures and disputes, digital health, clinical trials, manufacturing, distribution, supply chain and parallel trade, reimbursement, and repurposing;
- Establish objectives, operational plans and performance indicators for EFPIA’s legal and regulatory strategy
- Coordinate and drive the work of relevant EFPIA working groups, as well as to other EFPIA teams as regards regulation and legal issues;
- Follow EU developments and opportunities, and formulate recommendations for EFPIA working groups Draft advocacy material and internal advice over 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.
Minimum qualifications:
- Master's Degree, with a good knowledge of EU, Pharmaceutical and Competition Law;
- 5 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.
Skills:
- Excellent analytical, attention to detail, communication (written and spoken) and organizational skills
- Strong team player skills and the ability to work harmoniously with a diverse working environment
- 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
EFPIA offers:
- A permanent contract with an ideal start date no later than 1 February 2020;
- Interested candidates should send their application by 20 January 2020, 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 3 main legal and regulatory challenges for the pharmaceutical industry.
this job offer is not open for applications
