Senior Regulatory Affairs Specialist, HUB Spain

Do you want to play a key role in ensuring compliance and smooth market access in pharmaceutical parallel trade? Join our Regulatory Affairs team and help us secure licenses and prepare packaging materials that put patient safety first.

The opportunity

As our Senior Regulatory Affairs Specialist in Spain, you will be responsible for obtaining and maintaining parallel trading licenses and preparing packaging materials according to SOPs, WIs, and applicable guidelines. Your work will ensure regulatory compliance, smooth production processes, and timely market access. You will handle dossiers, artwork, and documentation, while also staying up to date with regulatory requirements in your assigned end market.

We would like you to:

In this role, you will:

• Prepare and submit dossiers to acquire and maintain parallel trading licenses.
• Create and maintain packaging materials, artwork files, mock-ups, and item lists.
• Proofread packaging components, application files, and item lists to ensure accuracy.
• Manage and archive regulatory documentation, including packaging materials and authority-approved files.

You will also communicate directly with health authorities and external printing houses, monitor regulatory updates, and implement changes as required. Beyond your daily responsibilities, you will contribute to continuous improvement projects, training, and updates of working instructions and guidelines. Ad-hoc assignments from your manager may also be part of your role.

About you, our new colleague:

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

You bring:

• A Bachelor's or Master's degree in Pharmacy, Regulatory Affairs, Life Sciences, or an equivalent field.
• Minimum years of experience in the pharmaceutical industry.
• Professional proficiency in English (B2 level or higher) and fluent in local language (written and verbal)
  
• Experience in at least one of the following areas:
  • QA or RA within pharma.
  • Interaction with regulatory authorities.
  • Handling medicine forms and packaging materials in repackaging processes.
  • Experience with repackaging processes and machinery.
  • Proficiency in Adobe InDesign, Illustrator, Photoshop; knowledge of EULER (braille and text comparison software.
• Residence in the country where the role is based and a valid work permit.

Skills and competencies that will make you succeed
You have strong knowledge of regulatory dossiers and parallel distribution procedures and a solid understanding of packaging material design, proofreading, and archiving. 

You communicate effectively with authorities and external partners, and your work is characterised by accuracy and attention to detail in regulatory submissions. 

You are able to perform under strict guidelines and deadlines, while also maintaining a continuous improvement mindset, always seeking opportunities to optimise processes and systems.

Are your interested?

We'd love to hear from you if you want to be part of an international team ensuring compliance, efficiency, and patient safety. Please submit your CV via our career page.

We look forward to receiving your application

Do you want to know more 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.