SENIOR SCIENTIFIC SPECIALIST - INSPECTIONS
|Bedrijf||European Medicines Agency|
|Aantal uren per week||40 uur|
The European Medicines Agency (EMA) promotes and protects public and animal health in EU Member States, as well as the countries of the European Economic Area, by ensuring that all medicines available on the EU market are safe, effective and of high quality. EMA serves a population of approximately 400 million citizens living in the EU. EMA operates at the heart of the European medicines regulatory network - a unique collaborative model between over fifty national regulatory authorities for both human and veterinary medicines in the European Economic Area, EMA and the European Commission.
The Human Medicines Division oversees and manages human medicines throughout their lifecycle, from evidence generation planning, through evaluation and monitoring of medicines to interfacing with stakeholders to facilitate access and optimal use. The division also supports the European regulatory network to produce patient-centred high-quality scientific opinions.
We are looking for senior scientific specialists leading the Agency strategy to facilitate the regulation of advanced and innovative manufacturing of medicinal products and active substances. The role will involve leading relevant activities within the EU Medicines Regulatory Network, through interactions with experts from the 27 EU Member States, working groups/ Committees as well as with International Partners , the Commission and WHO .
The role will be located within the Agency’s Inspection Office and will also involve scientific and administrative support to Inspection Office tasks including inter alia, contributing to GMP guideline development, co-ordinating inspections, co-ordinating assessments of quality defects, support to the Agency GMDP Inspectors Working Group.
The successful applicant will be expected to progress the Agency and Network strategy in the following areas;
- Advanced and innovative manufacturing of active substances and medicinal products, including new Quality Control and Quality Assurance approaches arising from the use of inter alia, sensors, data analytics and artificial intelligence.
- Innovations in manufacturing facilities and manufacturing networks including decentralised manufacturing, modular systems and portable systems.
- Convergence with international partner authorities on the regulation, including GMP standards, for advanced and innovative applications and facilities.
- Enabling and facilitating post approval change management as per the ICH Q12 principles
On a daily basis, you will be cooperating with highly qualified professionals from 27 EU member states.
Link to the full role description of the Scientific Specialist outlining generic duties and responsibilities.
Apply if you meet these eligibility criteria:
- enjoy full rights as a citizen of a European Union Member State, Iceland, Liechtenstein or Norway;
- have a thorough knowledge of English (at least level C1) and a satisfactory knowledge of another official language of the European Union (at least level B2);
- have fulfilled any obligations imposed by applicable laws concerning military service.
- possess a university degree (minimum of four years) in Life Science (e.g. pharmacy, biology, chemistry, biochemistry) or Medicine (human/veterinary) or Engineering that must have been obtained by the closing date of this vacancy notice, and at least 9 years’ professional experience after obtaining the relevant degree, that must have been obtained by the closing date, in the field of the above-mentioned areas and duties.
- possess a university degree of three years in Life Science (e.g. pharmacy, biology, chemistry, biochemistry) or Medicine (human/veterinary) or Engineering that must have been obtained by the closing date of this vacancy notice, and at least 10 years’ professional experience after obtaining the relevant degree, that must have been obtained by the closing date, in the field of the above-mentioned areas and duties.
For general condition 1 and for specific conditions 1 and 2 you will be required to provide proof in the application form and at the interview stage. Failing to present these documents may result in the disqualification from the selection procedure.Only candidates eligible will be assessed by the Selection Committee in accordance with the Assessment Criteria below.
You will also need to have:
Out of the years of professional experience required above (eligibility - specific conditions), at least 5 years of GMP experience (specifically in the areas of GMP inspections, manufacturing of medicinal products for human or veterinary use, quality control, quality assurance and/or innovative manufacturing) in either a competent authority in the field of medicines regulation, the pharmaceutical industry or in a healthcare / academic setting should have been obtained in the scientific, regulatory, or procedural aspects of the research, development, authorisation, productions or supervision of human or veterinary medicines (including medicinal products containing medical devices and associated regulatory framework).
Skills & Knowledge
- Critical review and drafting of scientific and regulatory documents for expert and lay audiences;
- Knowledge and understanding of the EU pharmaceutical legislation and the regulatory framework for pharmaceutical products in the EU, including ICH guidelines relevant to the role, and their application;
- Presenting scientific, or regulatory matters at a high level (eg to experts);
- Proficient in MS Office suite.
Competencies you will need to have:
- Regulatory frameworks & strategy Advanced
- Applied Knowledge Management Advanced
- Scientific product lifecycle and procedure management Intermediate
- Adaptability and agility Intermediate
- Coping with Pressures and Setbacks Advanced
- Analysing and problem solving Advanced
- Ethics and Integrity Intermediate
- Team collaboration Advanced
- Customer centricity Advanced
- Results orientation Advanced
- Communication Advanced
- Cross-cultural sensitivity Advanced
- Continuous learning and self-development Intermediate
The assessment of competencies forms an important part of this selection process. EMA therefore advises you to refer to its Competency Framework for more information on the definitions of these competencies and their associated levels.
Nice to have:
- PhD and/or specialization in a relevant field of study (Medicine or Life science disciplines);
- Master’s degree in regulatory science, regulatory affairs, quality, manufacturing or pharmaceutical technology.
Background and/or work experience in the following areas:
- Novel/innovative manufacturing technologies or products (e.g. ATMPs, bedside manufacturing, continuous manufacturing);
- GMP for veterinary medicinal products or active substances;
- Inspection or manufacturing of substances of human origin/medicinal products revived from substance of human origin.
Skills and Knowledge
- Knowledge of the typical issues in quality, non-clinical, or clinical development in one or more therapeutic areas;
- Knowledge of general methodology for quality, non-clinical, or clinical development;
- Knowledge of trends and innovative developments in the area of pharmaceutical manufacturing and bordering legislation (e.g. medical devices);
- Knowledge of analytical methods and research skills.