Job Description

Do you want to work broadly with Regulatory Affairs in an international pharmaceutical company where you will combine operational regulatory work with process improvements, stakeholder management, and technical ownership?

We are looking for an experienced Regulatory Affairs Specialist to join our South of Europe HUB in Madrid. Here, you will become part of a growing international setup supporting multiple European markets while working closely with colleagues across Regulatory Affairs, QA, Product Development, and Operations.

The opportunity

You will join the Regulatory Affairs South of Europe HUB - a team responsible for handling submissions, approvals, and lifecycle management of parallel import licenses across several European markets.

The team currently consists of two Regulatory Affairs Specialists based in Madrid, working closely together in a highly collaborative and international environment. The role combines operational execution with ownership and continuous improvement, making it ideal for someone who enjoys both detail-oriented regulatory work and driving smarter ways of working.

In this role, you will independently manage complex regulatory tasks across assigned end markets while also contributing to process optimization, training, and operational excellence initiatives.

We would like you to:

• Acquire and maintain parallel trading licenses, including dossier preparation, submissions, and lifecycle management

• Prepare and proofread packaging materials, artwork files, mock-ups, item lists, and regulatory documentation

• Communicate with competent authorities and stakeholders across assigned markets

• Participate in continuous improvement initiatives and optimization of processes and systems

• Support onboarding and training of colleagues within the team

• Evaluate regulatory legislation changes and contribute to operational implementation

• Participate in projects as an operational SME within Regulatory Affairs

• Support maintenance of SOPs, working instructions, and guidelines

What we need you to have:

• 5+ years of experience within Regulatory Affairs

• A Master’s degree or PhD within Pharmacy, Health Sciences, Life Sciences, or similar

• Alternatively 8+ years of relevant Regulatory Affairs experience

• Strong understanding of EU regulatory requirements and procedures

• Professional proficiency in English

• Professional proficiency in either Spanish and Portuguese / Italian

• Experience working with packaging materials and documentation in a regulated environment

• A structured and detail-oriented approach combined with a proactive mindset

It is an advantage if you also have experience working with Adobe Creative Cloud in a technical or regulated environment.

What we offer:

• An international workplace with colleagues across Europe

• A role with both operational responsibility and influence on improvements and ways of working

• A collaborative and supportive team environment

• Opportunities for professional and personal development

• The possibility to work closely with multiple stakeholders and markets across Europe

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.