Sr Dir CMC Regulatory Affairs, Dublin

We are looking for a leader to guide our CMC & Combination Products regulatory team, supporting a global portfolio of drug and device products with a strong focus on the European Union. In this role, we work closely across functions to shape clear regulatory strategies that support development and keep submissions moving forward. You’ll play a central role in connecting teams, guiding decisions, and ensuring global regulatory alignment.

A Typical Day:

Leading a team delivering CMC and combination product regulatory activitiesShaping global regulatory strategies, with focus on EU requirementsAdvising senior leaders on regulatory direction and key considerationsOverseeing submissions and resolving complex compliance issuesWorking closely with regulators, partners, and external organisationsMonitoring new regulations and assessing impact on the portfolioImproving processes and identifying more efficient ways of workingSupporting team development through coaching and regular feedback

This Role May Be For You If You:

Enjoy leading teams and helping others grow in their rolesLike setting direction while staying close to the detailAre comfortable working with senior stakeholders across functionsPrefer a mix of strategic thinking and hands-on problem solvingBuild strong, steady relationships with external partners and regulatorsStay organised when handling multiple priorities at onceLook for practical, simple ways to improve how work gets doneValue clear, direct communication and keeping people aligned

To be considered, you should bring substantial experience in regulatory affairs with a focus on CMC and/or combination products, including developing and guiding global regulatory strategies. A bachelor’s degree is required (an advanced degree is strongly preferred). You should have experience leading teams, working with senior stakeholders, and a strong understanding of EU regulatory requirements. Experience supporting global submissions is essential.