German Speaking Regulatory Marketing Authorization Officer

As a Regulatory Marketing Authorization Officer, you will work closely with your colleagues in teams of up to 20 people. Your responsibilities will include obtaining and maintaining marketing authorizations, which are fundamental for pharmaceutical sales, and supporting entry into potential new markets. In your work, you will have direct contact with the Packaging Designer and the Operation Support Team as well as the Danish-Hungarian Product/Business Development departments to ensure compliance with regulatory requirements.

Help us drive better access of medicine and a better healthcare globally, by taking the first step of obtaining the authorizations!

Your responsibilities will involve:

• Acquiring and maintaining marketing authorizations.
• Creating the necessary submissions for authorizations and tracking them from the first documentation until authority decision.
• Monitoring relevant legal changes and verifying the accuracy of packaging materials and patient information leaflets.
• Maintaining precise administration regarding product lifecycle in our internal systems.
• Collaborating on graphic design tasks with Packaging Designer colleagues.
• Maintaining close relationships with Hungarian and Danish departments, as well as international authorities, all while keeping the broad business objectives in mind.

We are looking for you, if you have:

A quality-conscious mindset, precision, and accuracy. You're a pro-active individual who has excellent communication skills, both verbally and in writing. We're looking for you if you strive to solve problems and aren't deterred by the ever-changing dynamics of a rapidly growing company, also being a "team player" is not just a buzzword on your resume.

Qualifications and Skills:

• Bachelors degree or equivalent experience.
• 1+ years' experience in an administrative role.
• You are fluent in English and German, at least at an intermediate level (both spoken and written).
• You have confident IT skills in Word, Excel, etc.

It is an advantage if you:

• Know any additional European foreign language
• Have experience with document- and task-management systems
• Have experience or interest in the pharmaceutical/healthcare or legal field

Working Hours:

• Monday-Friday, 8 hours/day + lunch break
• 3 days in the office 2 days home office

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;
• Semi-annual 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 Medicover after 6 months of employment.

Do you want to know about us?

Follow us on Instagram and LinkedIn and get an insight into everyday life at Abacus Medicine. For job openings, check our Career page .

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 1,300 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 Operations Locations Budapest - Kerepesi út 52 Employment type Full-time