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Senior Manager, Regulatory, Drug development & Manufacturing
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About the team:

The Science Policy & Regulatory Affairs team works on the development and implementation of strategies to modernise development and evaluation of innovative therapies to accelerate their delivery to patients.

About the role:

The Senior Manager Regulatory, Drug Development & Manufacturing coordinates activities related to regulatory and development topics, including development of policies and position papers, implementation of multi-stakeholder projects, interactions with regulatory authorities (European Medicines Agency, national regulators, European Commission) and support on regulatory matters to other teams at EFPIA.  He/She reports to the Director Regulatory Strategy.

Responsibilities include: 

  • Coordination of expert groups, e.g. Clinical Research, Early Safety and Pharmacovigilance, and as needed, support to other working groups and strategic committees.
  • Providing regulatory affairs input to cross-functional groups internally/externally
  • Leading response preparation on internal/external questions
  • Overseeing the EFPIA response to scientific guidelines and consultations represent a balanced view from membership
  • Tracking and communicating key regulations and policy changes in the dedicated policy area and identifying strategies and next steps with help from EFPIA cross-functional or expert working groups
  • Representing EFPIA at relevant external meetings/events

Minimum qualifications:

We are looking for professionals with these required skills to achieve our goals: 

Technical & knowledge:

  • Master’s Degree in pharmaceutical sciences/pharmacy or equivalent scientific degree (biology, chemistry, law)
  • At least 3 years of experience in pharmaceutical industry, drug regulatory authority or industry trade association / healthcare policy work
  • Familiarity with the functioning of the EU Regulatory Network and EU institutions
  • Professional fluency in English in written and verbal, ability to draft position papers and memos and experience in public presentations.
  • Relevant computer literacy skills 

Soft skills:

  • Strong organisational and project management skills
  • Self-motivated, dynamic, and decisive
  • Ability to independently lead and coordinate teams and projects
  • Strong team player
  • Ability to represent diverse opinions of a group and to reach consensus
  • Ability to adapt to constantly evolving external and internal environment

Preferred qualifications: 

If you have the following characteristics it would be a plus: 

  • Knowledge and familiarity of collaboration with different stakeholder groups and demonstrated track-record in successful interactions leading to tangible results in scientific or regulatory affairs or regulatory policy.

EFPIA offers:

  • A permanent contract.
  • Interested candidates should send their application by 30 April 2023 and address any question on the position to vacancy@efpia.eu.
  • The application should consist of:
    • CV
    • Motivation letter of max 1-page
    • Freely formulated max 1-pager of your thoughts on “Current and future challenges in medicines regulatory framework”

About EFPIA:

The European Federation of Pharmaceutical Industries and Associations (EFPIA) represents the biopharmaceutical industry operating in Europe. Through its direct membership of 37 national associations, 38 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.

EFPIA Healthcare Systems – Intern
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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, and in collaboration with health and research players, EFPIA’s mission is to create an environment that enables our members to discover, innovate, develop and deliver new therapies and vaccines for people across Europe, as well as contribute to the European economy.   

We have a small but dynamic Healthcare System team working on policy and outreach relating to the organisation and financing of healthcare and the role of the pharmaceutical industry for sustainable healthcare systems. We are looking for extra support from a reliable and motivated intern with a demonstrated interest in public finances, economy and health, and a proficient level of English. 

Role and responsibilities
 

The intern would be part of the Healthcare Systems team, but also support other teams when relevant. Responsibilities would include: 

  • Collection, compilation and updating of data and evidence relating to European health, healthcare, economy and pharmaceutical industry, including on the value of innovative medicines 
  • Digest reports relating to European economy and health (including European Commission Semester documents, OECD reports and studies produced by other EFPIA teams) and draft summaries, compilations, presentations or comments as appropriate 
  • Doing desk research on economic and health policy topics 
  • Conduct horizon scanning in relevant policy areas as relevant, including European healthcare reform 
  • Assist in the execution of projects and meetings led by other team members and staff (including organisation of events and minute taking, and as appropriate proof-reading of internal and external documents and support in presentation preparations) 

Candidate profile 

  • Right to work and live within the EU 
  • Master Degree in EU policy, health studies, economics, or similar relevant diplomas 
  • Academic merits in health economics would be highly valued 
  • Professional fluency in English 
  • Good knowledge of MS Office software package, including Excel and PowerPoint 
  • Good knowledge of European healthcare and life science sectors would be an asset 
  • Good knowledge of or previous experience with European institutions and decision-making would be an asset  

Skills 

  • Good project management skills, ability to manage multiple tasks under pressure and respect deadlines 
  • Excellent drafting skills 
  • Ability to assume different tasks, working independently or in a supporting role as required 
  • Team player with good interpersonal skills 
  • Service minded 
  • Open and positive mindset and ability to easily establish contacts through networking 
  • Able to think flexibly about evidence needs of the organisation  

Terms and conditions 

You will be offered a paid professional integration agreement (immersion professionelle) for maximum 6 months. You must not have already completed a 12-month immersion professionelle or have been in full time professional employment yet. Working hours are from 09:00 until 18:00 Monday to Friday with a one-hour break for lunch. The intern will be entitled to 6 days holiday plus national bank holidays. 

To apply, please send a maximum two-page CV and a maximum one-page cover letter to vacancy@efpia.eu with the subject Healthcare Systems Intern” as soon as possible. 

Starting date: August 2023 

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 indicated page limits for the CV and cover letter. We are grateful for your understanding and your interest in EFPIA.
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