Regulatory Affairs Manager - Dr. Max Own Label
Dr. Max Own Label provides a wide range of pharmaceutical products sold exclusively in Dr. Max pharmacies in 6 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 Manager who will be in charge of registrations of steadily growing medicine portfolio. This person will lead a small team responsible for life-cycle management and cooperate with Senior Regulatory Affairs Manager and other teams in RA division to ensure regulatory compliance for medicine portfolio. This is a great opportunity for those with experience in registration of medicines willing to build their career in a growing and successful company!
Required education: University Degree
Required languages: Czech or Slovak, English (advanced)
Employment form: Full-time work
- Preparation of submissions of new registrations, extensions, variations and renewals (DCP, MRP, national procedures) within CEE
- Leading and advising to members of one part of RA team
- Cooperation with Senior RA Manager to ensure regulatory compliance for licensed 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
- University degree - Pharmaceutical, Medical or Chemistry
- Experience with EU Regulatory Affairs for min. 3 years
- Knowledge of registration processes (new authorisations, renewals, variations) and dossier for medicines
- Communicative, proactive and open mind
- 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, advanced level of Czech/Slovak
- 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
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.