Regulatory Marketing Authorization Officer (German B1 knowledge)

Join us as a Regulatory MA Officer and help drive smooth, compliant marketing authorization processes for the German and Austrian markets.

If you're detail-oriented, proactive, and eager to support getting medicines to patients faster, this role is a great next step in your regulatory career.

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:

• Obtain and maintain marketing authorizations in line with SOPs, WIs, and regulatory guidelines
• Prepare and manage submissions throughout the full lifecycle
• Communicate with authorities and Trademark Holders for the assigned markets
• Monitor regulatory and procedural changes and apply them in daily work
• Handle, organize, and archive regulatory documentation and related administrative tasks
• Prepare and update working instructions and guidelines
• Collaborate with other departments and support smaller projects and ad-hoc tasks
• Participate in internal trainings and contribute to team support.

What we need you to have:

• 3+ years of experience in the pharmaceutical or regulatory field
• University degree in Pharmacy, Life Sciences, Regulatory Affairs, or a related area
• English at B2 level and German from B1 level
• Basic understanding of regulatory requirements for the German market is an advantage
• Precision, independence, and strong collaboration skills.

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.

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