SrDirCMCRegulatoryAffairs

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 activities * Shaping global regulatory strategies, with focus on EU requirements * Advising senior leaders on regulatory direction and key considerations * Overseeing submissions and resolving complex compliance issues * Working closely with regulators, partners, and external organisations * Monitoring new regulations and assessing impact on the portfolio * Improving processes and identifying more efficient ways of working * Supporting team development through coaching and regular feedback ### This Role May Be For You If You: * Enjoy leading teams and helping others grow in their roles * Like setting direction while staying close to the detail * Are comfortable working with senior stakeholders across functions * Prefer a mix of strategic thinking and hands-on problem solving * Build strong, steady relationships with external partners and regulators * Stay organised when handling multiple priorities at once * Look for practical, simple ways to improve how work gets done * Value 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 gl