Do you want to play a key role in ensuring compliance and smooth market access in pharmaceutical parallel trade?

The opportunity

As our Regulatory Affairs Specialist, you will be responsible for obtaining and maintaining parallel trading licenses and preparing packaging materials for Italy and Spain.

Your work will ensure regulatory compliance, efficient production processes, and timely market access. You will handle dossiers, artwork, and documentation while staying up to date with regulatory requirements across your assigned markets.

You will collaborate closely with internal stakeholders, health authorities, and external partners, playing an important role in ensuring that our medicines reach patients safely and efficiently.

The role is based in Madrid together with our current Regulatory Affairs Specialist - and the rest of the Spanish Business Development team.

Your responsibilities

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 according to SOPs and guidelines.

• Proofread packaging components, application files, and item lists to ensure accuracy and compliance.

• Manage and archive regulatory documentation, including packaging materials and authority-approved files.

• Communicate directly with health authorities and external printing houses.

• Monitor regulatory updates and implement required changes.

• Contribute to continuous improvement initiatives, training activities, and updates of working instructions and guidelines.

• Support ad-hoc assignments from your manager when needed.

About you

We are looking for a structured, detail-oriented professional who thrives in a regulated environment and enjoys working with multiple stakeholders across countries and functions.

You are proactive, accurate, and able to manage deadlines without compromising quality.

You bring

• A Bachelor’s or Master’s degree in Pharmacy, Regulatory Affairs, Life Sciences, or a related field.

• Minimum 2 years of experience in the pharmaceutical industry.

• Regulatory Affairs within pharma.

• Professional proficiency in both Spanish and Italian (written and spoken) - this is a mandatory requirement.

• Professional proficiency in English (B2 level or higher).

Experience in one or more of the following areas will be considered an advantage:

• Interaction with regulatory authorities.

• Handling medicine forms and packaging materials in repackaging processes.

• Experience with repackaging processes or machinery.

• Proficiency in Adobe InDesign, Illustrator, and Photoshop.

• Knowledge of EULER (Braille) and text comparison software.

You must reside in the country where the role is based and hold a valid work permit.

Skills and competencies for success

You have strong knowledge of regulatory dossiers and parallel distribution procedures and a solid understanding of packaging material design, proofreading, and documentation management.

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

You are comfortable working under strict guidelines and deadlines while maintaining a continuous improvement mindset and identifying opportunities to optimise processes.

Interested?

We would 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.