Regulatory Affairs Specialist - Dr.Max Private Label

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 1000 SKUs.

Dr. Max Private Label team is growing and we are searching for a Regulatory Affairs Specialist who will be in charge of preparation of submissions during life-cycle 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 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 the field of registration of medicines 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
• Translation of Product Information 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 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
• Willingness to learn, genuine interest in registration of medicines
• Ability to work independently and keep timelines
• Attention to details and ability to manage complexity
• Stress resistant
• Communication skills (ability to work in cross-functional teams)
• Fluent English, native level Czech
• 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.