Sr Dir CMC Regulatory Affairs

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.

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 eff...