Regulatory Affairs Specialist - Dr. Max Own Label
Dr. Max is the leading pharmacy chain in Central Europe. In every country where we are active, Dr. Max is dedicated to improving the level of health care available by guaranteeing access to a broad assortment of medicines and pharmacy services. Our pharmacies are currently present in 6 countries (Czech Republic, Slovakia, Poland, Romania, Serbia, Italy) with great expansion plans across Europe for the near future. Dr. Max Own Label provides a wide range of pharmaceutical products sold exclusively in Dr. Max pharmacies in all our countries. It includes licensed (Rx and OTC generic medicines), and non-licensed products (food supplements, cosmetics, vitamins, medical devices, etc.). Our team is growing and we are looking for a RA Spacialist to join our Non-Licensed team.
Required education: University Degree
Required languages: Czech or Slovak, English (advanced)
Employment form: Full-time work
- Being responsible for regulatory support of new projects within the non-licensed portfolio which includes food supplements, cosmetics, medical devices etc.
- Cooperation with the RA Manager to ensure compliance of the mentioned non-licensed portfolio with regulatory requirements
- Preparation of the master texts for the products
- Preparation of the technical files for product notification
- Communication and coordination related processes with affiliates (local-regional units), related departments and external partners ensuring services
- Keeps the notification database up-to date in the Helios system
- University degree in Pharmaceutical, Medical or Chemistry
- Some previous relevant experience on a similar position is needed
- Experience with food supplements/cosmetics/medical devices regulations will be considered as a huge advantage
- Ability to work independently and keep timelines
- Attention to details, analytical skills and ability to manage complexity
- Native Czech/Slovak and advanced level of English
- Working for the leading pharmacy chain in CEE with great expansion plans
- Space for professional growth within the growing organization
- Global-level job within headquarters
- Attractive financial compensation (salary and yearly bonus)
- Flexible working hours, possibility of 1 day home office/week
- 5 weeks of holidays, discount in Dr. Max pharmacies, meal allowance, fully paid Multisport card, public transport contribution, sabbatical leave, pension insurance contribution, referral bonus etc.
If you are interested in this opportunity, please send your CV to groupHR@drmax.eu
Dr. Max Group is a European pharmaceutical concern owned by Penta, an investment group established in 1994, operating primarily in the countries of Central and Eastern Europe. Their offices are located in Prague, Bratislava, Warsaw, and Limassol. The business areas of Penta Investments include long-term investing in healthcare, financial services, retail, manufacturing, media and real estate development. The companies of Penta’s portfolio employ more than 43,000 people, with more than 15,000 professionals working in healthcare. The group’s assets value reached €14 billion in 2022.