Regulatory Affairs Manager - 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 medicines), and non-licensed products (food supplements, cosmetics, medical devices, etc.), currently covering the portfolio of over 1400 products in total. Dr. Max Own Label team is searching for a Regulatory Affairs Manager who will lead a great team of 3 RA specialists. 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: Native Czech/Slovak and English (advanced)
Employment form: Full-time work
- Leading and mentoring of the RA Labelling team to ensure effective collaboration, continuous improvement, and high performance
- Ensuring that all Product Information for medicinal products meets regulatory requirements through effective team leadership, strategic planning, and proactive communication with regulatory authorities
- Overseeing the whole agenda related to Product Information, safety variations and notifications, mock-ups in RA point of view and Parallel Import/Distribution, ensuring adherence to submission timelines and regulatory compliance
- Ensure compliance with deadlines for submission of safety variations and EUCSI comparison
- Participate in the preparation of advertising materials (abbreviated SmPCs)
- Serve as the primary liaison with regulatory authorities in matters relating to Product Information, facilitating timely and effective communication
- University degree in Life Sciences (Pharmacy, Chemistry, Life Science or related fields)
- Minimum 4 years of experience in regulatory affairs within the pharmaceutical or medicinal products industry
- Previous relevant experience in managerial role at least 1 year
- Excellent communication and interpersonal skills, with the ability to build and maintain effective relationships with the team and regulatory authorities
- Demonstrated expertise in managing regulatory submissions, registrations, renewals and variations mainly focusing on Product Information
- Native in Czech/Slovak 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
- Temporary job as a substitute for parental leave (2 years)
- 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.