Dr.Max is the leading omnichannel 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 services, through our pharmacie and online. Pharmacies are currently present in 6 countries (Czech Republic, Slovakia, Poland, Romania, Serbia, Italy), with further expansion plans across Europe for the future.
Regulatory Affairs Specialist with Slovak
Dr.Max private label provides a wide range of pharmaceutical products sold exclusively in Dr.Max pharmacies in all our countries. It includes licensed (Rx and OTC medicines), and non-licensed products (food supplements, cosmetics, vitamins, medical devices, etc.), currently covering the portfolio of about 800 SKUs.
Dr. Max Private Label team is growing and we are searching for a Regulatory Affairs Specialist with Slovak language who will be in charge of preparation of submissions during life-cycle of steadily growing portfolio of licensed products (generics) in the Private Label, as well as preparation of translations of product information to Slovak language. This person will cooperate with Regulatory Affairs (RA) Manager to ensure regulatory compliance for licensed portfolio.
This is a great opportunity for fresh graduates of pharmaceutical or medical university or those with short experience willing to build their career in a growing, successful company.
What will be your responsibilities?
- Preparation of submissions of variations, renewals (DCP, MRP, national procedures) within CEE
- Cooperation with RA Manager on preparation of new registrations
- Cooperation with RA Manager to ensure regulatory compliance for licensed portfolio in all countries with the focus on Slovakia
- Translation of Product Information to Slovak language
- Coordination of local representatives
- Cooperation with other internal teams and service providers
- Review and approve artworks
- Publishing of eCTD sequences
- Supplier visits as needed
- On-going learning of the regulatory / legal environment related to the licensed products
What do we expect from you?
- University degree, Life Science or Pharmaceutical or Medical
- Experience with EU Regulatory Affairs would be an advantage but we are open to fresh graduates as well
- Fluent English and native level Slovak
- Willingness to learn
- Ability to work independently and keep timelines
- Attention to details and ability to manage complexity
- Flexibility in dealing with different cultures
- Communication skills (ability to work in cross-functional teams)
- Ability to handle change (of rapidly growing company, team, processes)
What do we offer?
- Working for the leading pharmacy chain in CEE with great expansion plans
- Responsible global level job with an impact on the business as a whole
- Space for professional growth within the growing organization
- Attractive financial compensation (salary and bonuses)
- Flexible working hours
- 5 weeks of holidays, discount in Dr. Max pharmacies, meal coupons, contribution to free time activities and many other benefits
If you are interested in this opportunity, please send us your CV to start an inspiring discussion.
Informace o pozici
- Na Florenci 2116/15, Praha – Nové Město
- Required education: University
- Required languages: English (Advanced), Slovak (Advanced)
- Benefits: Bonuses, Cell phone, Discount on company products / services, Notebook, Contributions to the pension / life insurance, Flexible start/end of working hours, Meal tickets / catering allowance, Holidays 5 weeks, Refreshments on workplace, Occasional work from home, Individual schedules of working hours
- Listed in: Research and development, Health and social care, Pharmaceutical
- Employment form
- Employment form: Full-time work
- Contract duration
- Contract duration: Permanent
- Employment contract
- Employment contract: employment contract
- Employer type: Employer
Also suitable for graduates.
+420 703 400 801