21 ago
|
Abacus Medicine Group
|
Madrid
21 ago
Abacus Medicine Group
Madrid
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
📌 Associate Specialist, Regulatory Affairs HUB SoE (Madrid)
🏢 Abacus Medicine Group
📍 Madrid