Regulatory Affairs Specialist

Are you detail-oriented and passionate about regulatory compliance? Join our team to handle parallel trading licenses, prepare packaging materials, and ensure everything runs smoothly from dossier submission to production. You'll manage artwork, item lists, proofreading, and documentation — all while keeping processes compliant and efficient. Make an impact in a role where precision and organization drive success

The opportunity
We are looking for a detail-oriented and proactive professional who thrives in a structured, regulated environment and enjoys collaborating with multiple stakeholders.

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

• Acquiring and maintaining parallel trading licenses (dossier updates and submissions).
• Preparing packaging materials (artwork files, mock-ups, and other graphic materials).
• Preparing and maintaining the item list.
• Communicating with authorities in the assigned end market, and at the same time communicating with internal and external printing houses.
• Monitoring and implementing changes in procedures and guidance from health authorities.
• Participating in projects regarding process, system, and continuous improvements.
• Assisting with the preparation and maintenance of working instructions and guidelines, ensuring updates are implemented.
• Performing ad-hoc tasks assigned by manager.

What we need you to have
:

• Master's/Bachelor's degree in Pharmacy, Regulatory Affairs, Life Sciences, or equivalent field.
• Minimum 2 years' experience in life sciences industry.
• Professional conduct in English (B2 level or above).

• Experience in at least one of the following areas:

• QA or Regulatory Affairs

• Interaction with regulatory authorities
• Working with different medicine forms and packaging materials in repackaging processes
• Experience with repackaging processes and production machinery
• In-depth knowledge of Adobe InDesign, Illustrator, and Photoshop, is a plus

Skills and competencies that will make you succeed

• Strong technical knowledge of regulatory dossiers and parallel distribution procedures.
• Solid understanding of packaging material design, proofreading, and archiving.
• Effective communication with authorities and external partners.
• Strong organizational and documentation management skills.
• Accuracy and attention to detail in regulatory submissions and proofreading.
• Ability to work within strict guidelines and deadlines.
• Continuous improvement mindset, seeking optimization in processes and systems.

Please note, training for this role will be held at our headquarters in Denmark.
Participants are welcome to travel in and out Monday through Friday, or extend their stay over the weekends if preferred.

All travel and accommodation expenses will be fully covered by Abacus Medicine Group.

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.

Are you interested?

If you want to apply, please use the
apply link
and attach your resumé.

We look forward to receiving your application

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.

Do you want to know about us?

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