With its ten faculties, Masaryk University is the largest university in Moravia and the third largest employer in the South Moravian Region. Within the MU, the Faculty of Medicine is a prestigious educational and research institution that cooperates with important external partners not only in the Brno research area.
The CREATIC Centre of Excellence - Central European Centre for Advanced Therapies of the Faculty of Medicine, Masaryk University in Brno was established on 1 January 2024 and focuses on research, development and production of advanced therapies.
LRI CZECRIN - Czech National Clinical Research Infrastructure is part of CoE CREATIC and the Czech national node of the European Network of Clinical Research Infrastructures ECRIN-ERIC.
Within CREATIC and CZECRIN, we are involved in the development of innovative new products in a number of areas, we are conducting national and international clinical research projects and working closely with clinical sites in our country and across the EU. Right now, we are looking for a new member to join our RA team to ensure the smooth running of RA processes and help new products reach patients.
You can find out more about us on our websites https://creatic.muni.cz/ and https://czecrin.cz/.
The scope of your work will be:
- Coordination of regulatory processes and projects
- Regulatory analysis of innovative projects and evaluation of information in terms of national and international requirements
- Preparation and implementation of RA project plans and strategies, collaboration on new product development plans
- Preparation of RA documentation for registration and notification processes (LP, ZP, etc.)
- Monitoring of EU and local legislation
- Collaboration with development teams on new projects
- Cooperation and coordination of activities with regulatory authorities including scientific advises
Required qualification:
- University degree (pharmacy, medicine, natural sciences)
- Experience in healthcare regulation (min. 3 years of experience)
- Experience in ATMP an advantage
- Experience in project and team management an advantage
- Communication, presentation, negotiation and organizational skills
- Proficient PC user skills (MS Office) and ability to effectively use the internet, social networks and search tools to retrieve and process information
- Independence, focus, responsibility, reliability, flexibility, attention to detail
- Willingness to find new ways and solutions to challenges and a desire to learn new things
- Very good proficiency in English language (written and verbal - working with professional texts and documentation in English, communication with partners and authorities abroad)
- Good knowledge of Czech/Slovak language an advantage
If you are interested in our position but don't meet all the requirements, let us know anyway! We would also be happy to welcome a less experienced colleague to the team, who will be supported with training, education and expertise from our team.
We offer:
- You will become part of a newly established international university centre, the only one of its kind in the Czech Republic, focused on rare diseases of paediatric and adult patients, for whom the scientific results of the centre mean an increased chance of survival and quality of life
- Professional background, new knowledge and experience, opportunity for personal and professional growth
- Motivating, independent and responsible work in a friendly team
- Flexible working hours
- Employee benefits (meal allowance/meal allowance, 6 weeks of vacation, pension contribution, tick-borne encephalitis vaccination, etc.)
Workplace: Palachovo nám. 726/3, 62500 Brno
Type of contract: 1 year fixed-term contract, with the possibility of further extension
Job type: fulltime, 40 hours per week
Salary: 45 000 – 75 000 Kč (according to experience)
Start date: immediately or by agreement
How to apply?
Please send your application, together with your CV, motivation letter, desired salary and the earliest possible start date, by the above deadline via the e-application form - please use the link: Regulatory Affairs manager for Centre of Excellence CREATIC | Masaryk University