Associate Specialist, Regulatory Affairs HUB SoE

Abacus Medicine Group; Madrid; Presencial; EUR 70.000 - 100.000; Jornada completa

Descripción de la vacante

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.

Formación

• 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.

Responsabilidades

• 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.

Conocimientos

Regulatory Affairs

Stakeholder management

Attention to detail

Independent working

Mentoring

Process improvement

English proficiency

Spanish proficiency

Portuguese/Italian proficiency

Communication

Educación

Master’s degree in Pharmacy/Health Sciences/Life Sciences

PhD in related field

10+ years Regulatory Affairs experience

Herramientas

Adobe Creative Cloud

Descripción del empleo

Are you an experienced Regulatory Affairs professional who enjoys taking ownership, challenging existing ways of working and turning regulatory expertise into practical improvements? Would you like to work across Southern European markets while helping colleagues and the wider team raise the bar? Then this could be your next move.

The opportunity

We are looking for an experienced Senior Regulatory Affairs Specialist to join our Regulatory Affairs South Europe HUB in Madrid, Spain.

As Senior Regulatory Affairs Specialist, you will be responsible for regulatory activities across assigned Southern European end markets, with a particular focus on obtaining and maintaining parallel trading licences and ensuring that regulatory documentation and packaging materials comply with applicable requirements.

This is a hands-on specialist role where you will manage your own regulatory activities while also using your experience to strengthen the way we work. We are looking for someone who does not simply follow established processes, but who takes ownership, asks questions and identifies opportunities to make processes more effective.

You will work closely with colleagues across Regulatory Affairs, Quality Assurance, Product Development and Operations, as well as with health authorities, industry associations, regulatory consultants and service providers.

As an experienced member of the team, you will also act as an operational subject matter expert, guide colleagues, contribute to new initiatives and help develop our regulatory processes and standards.

You will join a team consisting of four Regulatory Affairs Specialists and one Regulatory Affairs Manager, based in our Madrid office.

We Would Like You To

In this role, you will:

• 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.

About You, Our New Colleague

You are an experienced Regulatory Affairs professional who is comfortable taking ownership and making decisions within your area of expertise.

You work independently and systematically, and accuracy comes naturally to you. At the same time, you are curious about how things can be done better. You are comfortable challenging existing ways of working, proposing improvements and taking an active role in implementing them.

You enjoy sharing your knowledge and supporting colleagues, but you are equally comfortable rolling up your sleeves and handling the operational regulatory work yourself.

We Imagine That You Have

• 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.

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 1,750 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.