Regulatory Affairs Specialist - Dr.Max Private Label Licensed Portfolio

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 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 generic medicines), and non-licensed products (food supplements, cosmetics, vitamins, medical devices, etc.), currently covering the portfolio of about 1000 products in total. Dr. Max Private Label team is growing and we are searching for a Regulatory Affairs Specialist who will be in charge of registrations of one part of steadily growing portfolio of licensed products (generics) in the Private Label. This person will cooperate with Regulatory Affairs (RA) Manager to ensure regulatory compliance for medicine portfolio. This is a great opportunity for fresh graduates of pharmaceutical or medical university or those with short experience in registration of medicines willing to build their career in a growing, successful company.

Adress: Na Florenci 2116/15, Praha – Nové Město
Required education: Bachelor's 
Required languages: Czech, Slovak or other CEE language (Proficient), English (Advanced)
Employment form: Full-time work
What will be your responsibilities?
  • Preparation of submissions of variations, renewals, notifications (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
  • Communication with health authorities and suppliers
  • Preparation of Product Information (PI) and translation of PI to local language
  • Coordination of local representatives
  • Cooperation with other internal teams and service providers
  • Review and approve artworks
  • Publishing of eCTD sequences
  • On-going learning of the regulatory / legal environment related to the medicine
What do we expect from you?
  • University degree, Pharmaceutical, Medical or Chemistry
  • Experience with EU Regulatory Affairs would be an advantage,
  • Proven interest and at least theoretical knowledge of registration of medicines is a must
  • Communicative, proactive and open mind
  • Ability to work independently and keep timelines
  • Attention to details and ability to manage complexity
  • Stress resistance
  • Flexibility in dealing with different cultures and cross-functional teams and handle change (of rapidly growing company, team and processes)
  • Fluent English, native level Czech or Slovak
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 allowance, contribution to free time activities and many other benefits

If you are interested in this opportunity, please send your CV to [email protected]


Dr. Max BDC, s.r.o.

Na Florenci 2116/15
110 00 Prague 1
[email protected]

The Dr.Max Group is owned by the Central European investment group Penta, established in 1994. Penta’s business areas include health care, financial services, manufacturing, retail businesses and real estate development. Penta manages a single fund for its partners, the shareholders in the company. The companies in Penta’s portfolio employee more than 43,000 people, and the Group’s asset value reached € 11.1 billion in 2020. Penta operates in more than 10 European countries and has offices in Prague, Bratislava, Warsaw and Munich.

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