Regulatory Affairs Specialist - Dr. Max Own Label
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, medical devices etc.). Our team is growing and we are looking for a RA Specialist to join our Licensed team.
Required education: University Degree
Required languages: Native Czech, English (advanced)
Employment form: Full-time work
- Ensure that all Product Information and mock-ups for medicinal products meet local and international regulatory requirements
- Supervise and mentor junior colleagues of RA Labelling team
- Submission of safety variations and notifications in line with deadlines
- Ensure preparation of national RTD
- Participate in the preparation of advertising materials (abbreviated SmPCs)
- Ensure that national mock-ups are prepared in line with local regulatory requirements and approved Product Information
- Update of RA database in line with submissions/approvals
- Serve as a contact person for communication with regulatory authorities in matters relating to Product Information and national mock-ups
- Address regulatory inquiries and proactively engage with authorities to support product approvals and compliance initiatives
- Collaborate with cross-functional teams to support regulatory submissions and ensure alignment with overall business strategies
- Act in compliance with all concerned SOPs
- Cooperate with others on product recalls/investigation of complaints and/or deviations/incidents
- Cooperate with others on CAPA implementation
- University degree in Life Sciences (Pharmacy, Chemistry, Life Science or related fields)
- Minimum 3 years of relevant experience in RA within the pharmaceutical or medicinal products industry
- Previous experience with Product Information preparation and updates is a must
- Good knowledge of local and international regulatory requirements and guidelines related to Product Information
- Attention to details, reliability and ability to meet deadlines
- Excellent communication and interpersonal skills, with the ability to build and maintain effective relationships with colleagues and authorities
- Native Czech speaker and advanced level of English
- Working for the largest pharma retail company in CEE with great expansion plans
- A company with a meaningful purpose, an outstanding customer value proposition within an industry offering a resilient, non-cyclical growth pattern
- Global-level job within headquarters with a group-wide impact
- Space for professional growth within a growing organization
- Attractive financial compensation (salary and yearly bonus)
- Flexible working hours, possibility of 1 day/week home office
- 5 weeks of holidays, discount in Dr. Max pharmacies, meal allowance, Multisport card fully covered by employer, public transport contribution, sabbatical leave, pension insurance contribution, referral bonus etc.
If you are interested in this opportunity, please send your CV to groupHR@drmax.eu
Dr. Max Group is a European pharmaceutical concern owned by Penta, an investment group established in 1994, operating primarily in the countries of Central and Eastern Europe. Their offices are located in Prague, Bratislava, Warsaw, and Limassol. The business areas of Penta Investments include long-term investing in healthcare, financial services, retail, manufacturing, media and real estate development. The companies of Penta’s portfolio employ more than 43,000 people, with more than 15,000 professionals working in healthcare. The group’s assets value reached €14 billion in 2022.