Regulatory Affairs Associate Specialist

Help bring trusted medicines to patients across Europe. Join Abacus Medicine as an RA Associate Specialist and take ownership of regulatory activities that keep our parallel-traded medicines compliant, accurate, and available. Based in our Alkmaar office, you will join a collaborative team where you can build your expertise, improve the way we work, and develop your professional career

The role

As RA Associate Specialist, you will independently manage well-defined regulatory activities for your assigned End Markets. You will prepare and coordinate national new license applications, maintain existing licenses throughout their lifecycle, and ensure that dossiers, packaging materials, item lists, notifications, and supporting records meet applicable EU requirements and internal procedures.

You will work with a great degree of autonomy, taking accountability for the quality, accuracy, and timely delivery of your assignments. Alongside day-to-day regulatory work, you will share knowledge, support colleagues, and contribute to process, system, and operational improvements.

What you will do

• Prepare, coordinate, and submit national new parallel-trading license applications for assigned products and End Markets.

• Maintain existing licenses through lifecycle management, including dossier updates and submissions.

• Prepare artwork files, mock-ups, and other packaging materials, and assess whether existing materials can be reused.

• Prepare and validate item lists, and proofread packaging components, application files, and item lists.

• Own TMH notifications for assigned products and markets, including documentation review, regulatory assessment, and follow-up.

• Maintain complete, accurate, and compliant regulatory records, submissions, and supporting documentation.

• Communicate with competent authorities and relevant internal and external stakeholders.

• Monitor relevant legislation and assess the impact of regulatory changes.

• Author, edit, and review SOPs, working instructions, and guidelines in line with EU requirements and internal procedures.

• Escalate compliance risks, critical issues, and significant deviations to the Regulatory Affairs Manager in a timely manner.

• Plan and prioritize multiple activities, monitor progress, and adjust your approach to meet deadlines.

• Participate as an operational subject-matter expert in process, system, and operational improvement projects.

Meet the team

You will join the Regulatory Affairs NL Hub, part of the wider Regulatory Affairs Hub supporting End Markets across the Nordics, Benelux, Southern Europe, and the UK. The Alkmaar-based team consists of three RA Specialists and two assistants, and offers the flexibility to work from Amsterdam when required. On a daily basis you will collaborate closely with colleagues in Regulatory Affairs, Quality Assurance, Product Development, and Operations. Externally, you will engage with health authorities, industry associations, regulatory consultants, and service providers.

What you bring

• Your background can either be within Regulatory Affairs combined with a bachelor’s, master’s, or PhD in Pharmacy, Health Sciences, Life Sciences, Biomedical Sciences, Pharmaceutical Business Administration, or a related field; or 5+ years of Regulatory Affairs experience.

• A strong understanding of EU regulatory requirements and procedures, with the ability to interpret and apply them in practice.

• Professional proficiency in both Dutch and English, written and spoken.

• Excellent communication and stakeholder management skills.

• The ability to independently manage multiple activities and priorities while maintaining a high level of accuracy and quality.

• Proficiency in Microsoft Office applications and an interest in learning Adobe Creative Cloud or similar artwork management tools.

• Knowledge of quality systems, document control, data integrity, regulatory documentation, and EU dossier preparation is an advantage.

Interested?

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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.