Senior Compliance Specialist

5 days ago

Copenhagen, Copenhagen, Denmark Abacus Medicine Group Full time 80,000 - 120,000 per year

Are you passionate about regulatory compliance and thrive in a dynamic, fast-paced environment? Do you enjoy optimizing processes, shaping procedures, and driving regulatory excellence?
Then this could be your next move.
The opportunity
We are looking for a
Senior Compliance Specialist (SOP)
to join our Regulatory Affairs Development team at Abacus Medicine. In this role, you will play a key part in ensuring regulatory compliance across markets by developing and maintaining our regulatory procedures, workflows, and SOPs.

You'll be part of a growing and forward-thinking team that supports the continuous optimization and digital transformation of Regulatory Affairs. If you're motivated by cross-functional collaboration, complex problem-solving, and driving improvements, this is an opportunity to make a real impact.

We Would Like You To

  • Ensure compliance with local, regional, and global regulatory requirements.
  • Create, review, and maintain regulatory workflows, SOPs, and working instructions.
  • Act as the RA Super User for the SOP system - adding, updating, and overseeing compliance across the organization.
  • Monitor regulatory changes and communicate key implications to stakeholders.
  • Support cross-functional SOP updates as the RA representative.
  • Facilitate optimization projects and workflow sessions to identify and implement improvements.
  • Prepare and oversee KPI reporting within Regulatory Affairs.

You'll work closely with colleagues from Quality Assurance, Product Development, and Operations, and collaborate with health authorities, consultants, and industry associations.

About You, Our New Colleague
You bring both structure and curiosity to your work - you thrive on creating clarity and efficiency while continuously seeking smarter ways to operate.

You Also Have

  • Master's degree in Pharmacy, Regulatory Affairs, Life Sciences, or a related field.
  • Experience in Regulatory Affairs, the pharmaceutical industry, or SOP writing.
  • Strong understanding of EU regulatory requirements and procedures.
  • Excellent communication and stakeholder management skills.
  • Fluent in English, both written and spoken.
  • Detail-oriented yet able to see the broader value chain perspective.
  • Analytical and investigative mindset with a focus on compliance excellence.
  • Comfortable navigating complex, cross-functional environments.
  • Open-minded, adaptable, and proactive in driving change.

If you're motivated by improvement, collaboration, and impact, you'll feel right at home here.

Are your interested?
Please apply using the link below.

We look forward to receiving your application

Do you want to know more 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 1,500 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.

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