Senior Regulatory Specialist

Our client, a leading global consumer healthcare organisation, is looking for a Senior Regulatory Affairs Specialist to join their EMEA Regulatory Affairs team (hybrid working). This is a fantastic opportunity for an experienced regulatory professional to take ownership of a broad and varied portfolio, working across EU regulatory procedures and playing a key role in maintaining and expanding a well-established medicinal products portfolio.

What You'll Be Doing Leading on regulatory submissions in line with EU requirements (MRP/DCP), ensuring the ongoing maintenance and compliance of existing marketing authorisations Managing non-CMC lifecycle activities, including variations, renewals and safety updates Collecting and evaluating regulatory, quality, preclinical and clinical data to support compliance Liaising directly with Health Authorities, proactively seeking opportunities to expedite approvals Prioritising and managing multiple projects against agreed timelines Ensuring all assigned products remain compliant with local regulatory and quality requirements Supporting internal audits and inspections Partnering cross-functionally to manage crises and sensitive regulatory issues Driving local process improvements within the regulatory function What We're Looking For A relevant Bachelor's degree or higher Significant experience within a Regulatory Affairs , ideally within non-prescription EU procedures (MRP/DCP) Proven track record managing non-CMC lifecycle activities and safety updates Strong attention to detail and excellent organisational skills Confident communicator, able to simplify complex regulatory topics for varied audiences A collaborative mindset with a strong sense of ownership and accountability Comfortable operating in a fast-paced, matrixed, multicultural environment Fluent in English

Desirable

Experience within the consumer healthcare sector Understanding of cross-functional processes within a healthcare organisation

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