Senior Regulatory Specialist ( German B1 Knowledge)

Your knowledge can open doors for patients worldwide - become a key driver of regulatory excellence with us.

Come and join us as a Senior Regulatory Specialist.

The team:

You'll be joining an 8-member Regulatory Marketing Authorization team that supports the German and Austrian markets within a wider organization of 130 colleagues. Our group plays a key role in both national (member-state) marketing authorization processes and broader European regulatory activities.

We would like to:

According to the requirements of the assigned end market, you will be responsible for:

• Acting as a specialist within the team
• Acquiring marketing authorizations for medicines in line with SOPs, WIs, and relevant regulatory guidelines
• Maintaining existing marketing authorizations according to market-specific requirements and internal procedures
• Preparing and sending notifications to Trademark Holders in compliance with SOPs and WIs
• Managing end-to-end submission processes for the German and Austrian markets, ensuring high-quality documentation and smooth cross-functional collaboration
• Monitoring and interpreting regulatory and legislative changes, especially German-language regulations, and implementing them in daily operations
• Performing core operational regulatory tasks, including submissions, maintenance activities, compliance support, and documentation management
• Developing and maintaining SOPs, working instructions, and regulatory guidelines, and delivering internal trainings
• Participating in and occasionally leading ad-hoc projects, such as proof-reading or process improvement initiatives
• Providing professional guidance to junior colleagues and contributing to strategic decision-making within the regulatory function

What we need you to have:

• 10+ years of regulatory expertise in a national environment
• Master's/Bachelor's degree in Pharmacy, Regulatory Affairs, Life Sciences, or equivalent field
• Strong ability to track, interpret, and apply legislative and regulatory changes, especially for the German market
• Professional conduct in English (B2 level or above) and German (B1 level or above)
• Experience in communication with German authorities and confidence in handling market-specific regulatory expectations
• Ability to work independently, make well-founded decisions, and contribute to strategic thinking within the regulatory function
• Capability to manage the full submission lifecycle: from business request to complete documentation, collaborating with graphic designers and business development
• Willingness to participate in operational tasks, including submissions, maintenance, compliance, SOP and WI creation, trainings, and ad-hoc projects (e.g., proof-reading)

What we offer:

• Support for work-life balance, flexible management approach;
• Abacus is a long-term opportunity, we encourage your professional development with internal job opportunities and trainings;
• Quarterly company bonus;
• Cafeteria with optional elements;
• Annual salary increase;
• Employee referral program with high rewards;
• AYCM SportPass membership opportunity;
• Private health insurance package provided by Medicare after 6 months of employment.

Interested?

If you want to apply for the position, please follow the link and attach your CV.

Would you like to know more about us?

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Moving Healthcare. Moving You.

In Abacus Medicine Group, you'll experience the power of Moving Healthcare. With our change mindset, we're moving the industry and improving healthcare as we broaden access to medicine.

But it's not just about moving healthcare, it's about Moving You. You'll be part of a caring community of more than 1,750 people across the World. With us, you will be valued, empowered, and have a direct impact on driving change. Let's access the future of medicine and make a difference together. Your move.

Department Regulatory Locations Budapest - Kerepesi út 52 Employment type Full-time