Senior Specialist in Regulatory Affairs Development

Are you passionate about regulatory strategy, new markets, and creative problem-solving? Do you thrive in a dynamic, fast-paced environment where your work has a direct business impact? At Abacus Medicine, we're looking for a Senior Specialist in Regulatory Affairs Development who's ready to shape the future of market entry and M&A support. Join us and make a difference on a global scale.

The opportunity

You will join the newly established Regulatory Affairs Development team – a dynamic unit within Abacus Medicine that focuses on supporting strategic initiatives like new market entries, M&A, process improvements, and digital optimization. The team also plays a vital role in ensuring compliance across the entire Regulatory Affairs organization.

The "New Market Entry" team is quite new and currently consists of two team members based in Copenhagen, working collaboratively and cross-functionally with departments such as Business Development, Product Development, and Operations.

About the position

As Senior Specialist in Regulatory Affairs Development, your role is to lead and support regulatory activities related to entering new markets and supporting M&A processes. You will be hands-on with regulatory submissions, liaise with authorities, prepare documentation and packaging materials, and build new workflows to ensure smooth market transitions and compliance.

You'll also:

• Provide strategic regulatory input for M&A activities and business development initiatives.
• Build and maintain regulatory SOPs, workflows, and training materials that support operational excellence.
• Monitor evolving legislation, assess implications, and act on necessary changes.
• Collaborate cross-functionally to ensure alignment and efficiency throughout the product lifecycle.

What we need you to have:

We're looking for someone with both the technical knowledge and the mindset to drive change. You likely have a degree in Pharmacy, Regulatory Affairs, Life Sciences, or a related field, paired with at least five years of experience in Regulatory Affairs within the pharmaceutical industry.

You bring:

• A strong grasp of EU regulatory frameworks and procedures.
• The confidence to manage diverse stakeholders and communicate clearly across all levels.
• A structured yet adaptable way of working — and a genuine curiosity for new markets.
• Fluency in English, both written and spoken.

What we offer:

This is your opportunity to step into a high-impact role where your work directly supports Abacus Medicine's global growth journey. You'll join a collaborative and international team, where innovation is encouraged and your ideas can shape real outcomes.

• A purpose-driven culture with a clear mission to increase access to medicine.
• The freedom and responsibility to shape new regulatory processes from scratch.
• A steep learning curve through varied, hands-on projects across departments.
• An open, supportive workplace with flexibility and a healthy respect for work-life balance.

Are you interested?

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

We look forward to receiving your application

Do you want to know 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 1,500 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.