- Experience Level
- Experienced (non-manager)
Are you a scientist with excellent skills in chemical synthesis or analytical chemistry? Could you critically review data according to rules and participate in the decision-taking process for the Certification of Suitability to the monographs of the European Pharmacopoeia (CEP)? This position is an exceptional stepping-stone for a scientist wishing to develop a career in regulatory affairs.
The main responsibilities of the job:
Within the Certification of Substances Department, the successful applicant will provide professional scientific assistance and technical support to the CEP, for example validating applications, participating in the scientific evaluation of revisions of applications or gathering data on manufacturing sites for the inspection programme as well as ensure the link between the evaluation and inspection activities.
What we look for in someone to undertake this role effectively:
- have a higher education degree or qualification in a relevant area (for example: pharmacy, chemistry, biochemistry, food science)
- have a short professional experience (minimum 6 months) in at least one of the following areas:
- methods of synthesis or physicochemical analysis of pharmaceutical substances or medicinal products, acquired either at university (e.g. during Ph.D. studies), in the pharmaceutical industry, an official medicine control laboratory or a similar organisation
- scientific evaluation of marketing authorisation applications of medicinal products with a focus on the Common Technical Document (CTD) Module 3.2.S or Active Substance Master Files (ASMFs) in a licensing authority
- gathering and analysing scientific data, reporting on quality data relevant to marketing authorisation applications (CTD Module 3.2.S or ASMFs) for submission to competent authorities including experience in ensuring compliance with regulations during the preparation of submissions
- have a very good knowledge of one of the Council of Europe’s official languages (English) and knowledge of the other (French)
What we offer:
- a good insight into the European regulatory framework from the EDQM perspective; experience of evaluating a wide range of pharmaceutical substances produced by manufacturers worldwide; exposure to the documentary standards required by European regulatory bodies
- the chance to work in an ISO 9001 certified, multinational/multicultural workplace – over 20 nationalities work at the EDQM which is situated in the European quarter of Strasbourg (a UNESCO World Heritage site)
- highly competitive, income tax-free salaries, an attractive benefits package including health insurance, additional allowances such as family and expatriation allowances (as appropriate) and an annual training programme
Applications must be submitted by 02/08/2019 (midnight French Time) at the latest.
For more information on how to apply, please click the ‘Apply’ button.