Key Skills

Job Description

We are Akkodis. We put the talents, skills and ambitions of our Consultants first. Because we continuously offer you challenging projects, you continue to develop and you can realize your ambitions. This is our view on good employment practices. We, Akkodis Life Sciences, offer you internal and external projects in the field of QA, QC, PV, RA, R&D, Supply Chain and related. We have +/- 70 Consultants working at the EMA, Astellas, Unilever, Corbion, MSD, Organon, Aspen and many more! We, Akkodis Life Sciences, are looking for a Scientific Officer who can strengthen the team at our customer, European Medicines Agency, in Amsterdam. Role summary As a Product Lead in the Office of Therapies for Endocrine and Cardiovascular Diseases, you will ensure that high-quality and consistent scientific, regulatory and procedural input is provided throughout the product lifecycle. Your responsibilities are You will provide scientific coordination and regulatory and/or procedural support in relation to areas including: Development, evaluation and surveillance of medicinal products for human or veterinary use and of Maximum Residue Limits for substances for veterinary use; Referrals and related procedures for medicinal products for human or veterinary use; Management of requests for scientific advice, protocol assistance and parallel scientific advice with other decision makers, such as the FDA or HTA bodies, as well as qualifications; Preparing summary reports and supporting the coordination of initial assessments for orphan medicine designation, paediatric investigation plans or limited markets classifications; Delivery of high-quality product information through the assessment of invented names, product information and translations, mock-ups and specimens; Applying EU pharmaceutical legislation to the operations of the Agency; Contributing to the development of regulatory and/or procedural guidance documents and providing training as required; Coordinating and supporting Scientific Committee meetings, Working Parties, Working Groups and Advisory/Expert Groups; Responding to requests for scientific information received by EMA. Role specific duties & responsibilities Manage a portfolio of medicinal products throughout the complete product lifecycle, from initial marketing authorisation, including pre-submission activities, through post-authorisation; Provide regulatory and scientific support to scientific committees, EMA, the EU network of experts, the European Commission and other relevant stakeholders; Contribute to ensuring high-quality European Public Assessment Reports (EPARs) and product information for the assigned product portfolio from a clinical and non-clinical perspective; Work according to applicable SOPs, WINs, confidentiality requirements and other documentation relevant to the role. Communication and professional contacts In this position, you will work with colleagues and stakeholders across EMA and the wider European regulatory network. In particular, a scientific officer will: Liaise with internal and external stakeholders, interested parties and subject-matter experts; Coordinate, support and contribute to effective communication and stakeholder relationships; Communicate daily with colleagues across EMA and extended product teams regarding the management of regulatory procedures; Prepare and contribute to communication documents for allocated procedures; Contribute to the preparation of Scientific Committee meetings, Working Parties, Working Groups and Advisory/Expert Groups, including providing scientific support where applicable; Explain and interpret policies, systems and processes and contribute to responses to complex scientific or regulatory enquiries. Experience & Background A completed university degree of at least three years in a relevant Life Science field, such as Biology, Chemistry, Biochemistry or Pharmacy; Up to 3 years of full-time relevant professional experience; Experience within a competent authority in medicines regulation, the pharmaceutical industry, healthcare or an academic environment; Experience with the scientific, regulatory and/or procedural aspects of the research, development, authorisation, production or supervision of medicinal products; Experience working with medicinal products containing medical devices and the associated regulatory framework; Experience with the centralised procedure; Experience liaising with regulatory authorities and/or public health authorities. Skills & Knowledge Knowledge and understanding of EU pharmaceutical legislation and the European regulatory framework; Knowledge of the regulatory environment in which EMA operates; Strong organisational and prioritisation skills; Excellent communication and teamwork skills; Scientific writing skills; The ability to follow detailed processes and procedures; Initiative, diplomacy and good judgement; Tact and discretion when handling confidential information; Proficiency in the English language; Proficiency in Microsoft Office. What do we offer? Employment for 40 hours per week and the opportunity to work at innovative and progressing companies. You will be part of a fast growing Life Sciences team that is represented in different industries (biotech, pharma, food) and present in Life Sciences clusters in The Netherlands. Temporary contract, depending on the budget the possibility to extend; Attractive salary; The opportunity to work at the European Medicines Agency; Work-life balance with 24 to 36 holidays; Company fitness, health insurance and good pension scheme; Annual team events; Options to attend training, coaching and a personal development scheme; Career opportunities matching your aspirations and development. Are you interested in this challenge, or do you want to come in touch? Please contact your Talent Acquisition Specialist and apply via the button on this page.

Core Responsibilities

Manage a portfolio of medicinal products throughout their lifecycle, providing scientific, regulatory, and procedural coordination and support for assessments, authorizations, and post-authorization activities. Coordinate with EMA committees, experts, and stakeholders; contribute to high-quality assessment reports and product information; and support regulatory communications and guidance.

Requirements

A university degree of at least three years in a relevant life science field and up to three years of relevant professional experience are required. Candidates should have experience with medicinal product development or regulation, knowledge of EU pharmaceutical legislation, strong communication and scientific writing skills, and proficiency in English and Microsoft Office.

Benefits

• Health Insurance
• Pension Scheme
• Paid Holidays
• Fitness Program
• Training
• Coaching
• Personal Development
• Career Development
• Team Events