Manager, Regulatory Affairs HUB SoE
*Lead and develop a high\-performing Regulatory Affairs team to secure timely market authorisations, drive process optimisation, and act as a trusted regulatory partner to internal and external stakeholders.*
The opportunity
As our Manager, Regulatory Affairs HUB SoE, you will support the strategic direction, execution, and optimisation of regulatory development activities for the country. This is a hands\-on leadership role requiring strong subject\-matter expertise in Regulatory Affairs and proven experience managing a team of more than four employees.
You will ensure timely regulatory submissions, drive KPI performance, and serve as a key contact for health authorities in collaboration with colleagues across the organisation. You will lead and develop a team of regulatory professionals, coordinate cross\-functional input, and ensure full adherence to regulatory requirements while enabling commercial objectives.
We would like you to:
As Deputy Manager, you will be responsible for delivering regulatory outcomes through effective leadership, operational oversight, and regulatory expertise within a highly regulated pharmaceutical environment.
In this role, you will:
- Lead PI (parallel import) license applications and ensure their ongoing maintenance
- Translate strategic regulatory objectives into actionable operational plans
- Develop and optimize the parallel distribution marketing authorization function
- Guide the team through complex regulatory processes, ensuring compliance across markets
- Maintain ownership of internal procedures, ensuring they remain current, compliant, and continuously improved
- Manage team capacity, resource allocation, and performance delivery against KPIs
- Foster employee engagement, development, and retention within the team
- Contribute actively to change management initiatives that improve efficiency and regulatory alignment
You are a confident and communicative leader with deep experience in Regulatory Affairs and a strong track record of managing and developing teams. You thrive in structured, compliance\-driven environments and combine technical expertise with pragmatic stakeholder engagement.
What we require from you:
- Demonstrated professional experience in Regulatory Affairs within pharma, biotech, or a related healthcare setting
- Solid hands\-on experience with regulatory submissions, licensing, and compliance processes
- Bachelor’s or Master’s degree in Life Sciences, Pharmaceutics, Regulatory Affairs, or equivalent
- Minimum 3\+ years in a leadership position, within pharma/biotech or pharma services
- Experience working with structured administrative and documentation processes
- Fluent English, written and spoken
- Practical knowledge of artwork/design tools (InDesign, Illustrator, Photoshop) is a plus
- Residence in Spain and a valid work permit
Are you interested?
If this sounds like you, we’d love to hear from you. Please submit your CV using the apply link. 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.
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Department
Regulatory
Locations
Madrid
Remote status
Hybrid
Employment type
Full\-time
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