Regulatory Marketing Authorization Officer

Who are we?

Better Access. Better Healthcare.

At Abacus Medicine, our purpose is to improve global healthcare through better access to medicine. This has driven us to quickly become a global player in the parallel import industry and pharmaceutical services while not losing sight of our entrepreneurial mindset. Our company values: Innovative, Dedicated, and Caring, lead us on our way to continuously look for improvement and further ways to achieve our purpose. Join our 1,200 dedicated colleagues with more than 32 different nationalities in e.g. Denmark, Hungary, Germany, the Netherlands, the UK, Austria and Hong Kong.

Abacus Medicine Hungary Kft. started its activity in 2012 in Budapest and by today it has grown to be the largest member of the Abacus Medicine Group. Our more than 650 employees are working to provide easier access to vital medicines in various EU markets through our manufacturing, warehousing and quality assurance activities.

Your responsibilities:

As a Regulatory Marketing Authorization Officer, you will work closely you’re your colleagues in teams of up to 20 people within a department of 60. 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.

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.

Here are the qualifications we are seeking:

• You have a higher education degree;
• You already have relevant experience in an administrative role;
• You are fluent in English, at least at an intermediate level (both spoken and written);
• You have confident IT skills in Word, Excel, Acrobat;
• Have experience or interest in the life science/ medical/ pharmaceutical/ healthcare field

• It is an advantage if you:
• Know any additional European foreign language;
• Have experience with document- and task-management systems.

What we offer:

• An open and inclusive work environment where collaborative teamwork is a value;
• Support to work-life balance, flexible managerial attitude;
• Abacus is a long-term opportunity; we encourage your professional development with internal job opportunities and trainings;
• In addition to the monthly base salary and quality bonus;
• Optional cafeteria system;
• Yearly salary adjustment;
• Employee Referral Program with high remuneration;
• AYCM SportPass membership opportunity;
• Your loyalty is rewarded with Medicover private health package;
• Corporate events and gifts, annual team building framework.

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