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Pracovní místa dr.max

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Job Post Details

Regulatory Affairs Officer - Dr. Max Own Label - job post

Dr.Max Group
Praha
Plný úvazek
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Popis pracovní pozice

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Druh nabídky práce

  • Plný úvazek

Lokalita

Praha

Úplný popis pracovní pozice:

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.), currently covering the portfolio of about 1300 products in total. Dr. Max Own Label team is growing and we are searching for a Regulatory Affairs Specialist who will be in charge of registrations of steadily growing medicine portfolio. This person will cooperate with RA Manager to ensure regulatory compliance for medicine portfolio. This is a great opportunity for those with some previous experience in Regulatory Affairs of medicines in CEE willing to build their career in a growing company.

Address: Na Florenci 2116/15
Required education: University Degree
Required languages: Czech or Slovak, English (advanced)
Employment form: Full-time work
What will be your responsibilities?
  • Preparation and submission of quality variations (DCP, MRP, national procedures) within CEE
  • Cooperation with RA Manager on preparation of new registrations and extensions
  • Dossier management
  • Cooperation with RA Manager to ensure regulatory compliance for medicinal portfolio in all countries
  • Communication with health authorities and suppliers
  • Coordination of local representatives
  • Cooperation with other internal teams and service providers
  • On-going learning of the regulatory / legal environment related to the medicines
What do we expect from you?
  • University degree, Pharmaceutical, Medical or Chemistry
  • Experience with EU Regulatory Affairs for min. 1 year (advantage)
  • Knowledge of dossier for medicinal products (advantage)
  • Proven interest and at least theoretical knowledge of registration of medicines is a must
  • Ability to work independently and keep timelines
  • Attention to details and ability to manage complexity
  • 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 annual bonus)
  • Flexible working hours, possibility of home office
  • 5 weeks of holidays, discount in Dr. Max pharmacies, meal allowance, Multisport card etc.
  • Yoga lessons at workplace

If you are interested in this opportunity, please send your CV to groupHR@drmax.eu

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