Sr Dir CMC Regulatory Affairs

Job description

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: To be considered, you should bring substantial experience in regulatory affairs with a focus on CMC and/or combination products, including developing...