Senior Regulatory Affairs Specialist - Southern Europe Hub

Abacus Medicine Group

Madrid

On-site

EUR 70,000 - 100,000

Full time

14 days+

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Job summary

Abacus Medicine Group in Madrid, Spain, is seeking an experienced Senior Regulatory Affairs Specialist to join the Regulatory Affairs South Europe HUB. You will manage regulatory activities across Southern European end markets, focusing on parallel trading licences and compliant documentation.

This hands-on role requires ownership, initiative, and the ability to mentor colleagues, collaborate with QA, Product Development and Operations, and contribute to regulatory standards and initiatives.

Qualifications

5+ years of Regulatory Affairs experience combined with a Master’s degree or PhD in Pharmacy, Health Sciences, Life Sciences or a related field; or 10+ years of relevant Regulatory Affairs experience.
Strong knowledge of EU regulatory requirements and procedures, including experience managing regulatory documentation.
A proactive and improvement-oriented mindset – you take ownership, identify opportunities and are comfortable challenging existing ways of working.
Strong attention to detail and the ability to work independently, prioritise and manage multiple activities.
Strong communication and stakeholder management skills, with the ability to guide, mentor and share knowledge with colleagues.
A high level of English and Spanish, Portuguese and/or Italian, both written and spoken.
Experience using Adobe Creative Cloud in a technical environment.

Responsibilities

Prepare, submit and maintain parallel trading licences, including dossier preparation, regulatory updates and submissions.
Prepare and review packaging materials and regulatory documentation, including artwork files, mock-ups, item lists and application files, ensuring accuracy and compliance.
Manage regulatory documentation and lifecycle activities, including archiving authority-approved and submitted documentation and assessing whether existing packaging materials can be reused.
Communicate with competent health authorities and relevant stakeholders across your assigned markets and monitor regulatory and legislative changes.
Proactively identify and drive improvements to regulatory processes, systems and ways of working, and support new operational initiatives.
Act as an operational SME, guiding and mentoring colleagues, supporting onboarding and training, and sharing your regulatory expertise across the team.
Contribute to regulatory standards and projects, including SOPs, working instructions and guidelines, and participate as an SME in process and system optimisation initiatives.