We are supporting a growing, innovation led pharmaceutical organisation in the search for a Senior Director, Global Regulatory Affairs to play a key leadership role across both strategy and execution.

This individual will operate as a true system and people architect, shaping global regulatory frameworks, driving organisational change, and building scalable regulatory capabilities across the full product lifecycle. The position requires a leader who can operate at both strategic and operational levels, with the ability to influence senior stakeholders and lead leaders across a complex, international environment.

Key Responsibilities

• Define and lead global regulatory strategy across development programmes, spanning early development through to lifecycle management and post approval activities

• Act as a central architect for regulatory systems, processes and governance, ensuring alignment across regions and functions

• Drive the evolution of the regulatory organisation, embedding a mindset shift towards efficiency, scalability and cross functional collaboration

• Lead and develop senior regulatory leaders, building high performing teams across global and regional structures

• Oversee regulatory planning and execution across key markets, with a strong focus on Europe and alignment with global requirements

• Provide strategic guidance on submission pathways, lifecycle optimisation and regulatory risk management

• Ensure regulatory frameworks, processes and documentation align with ICH guidelines and GxP standards

• Partner closely with cross functional stakeholders including Clinical, CMC, Quality and Commercial teams to support integrated development strategies

• Support regulatory interactions with Health Authorities, ensuring high quality, consistent and compliant engagement

Experience & Requirements

• Strong experience within Global Regulatory Affairs, including leadership of complex, multi region regulatory strategies

• Demonstrated experience across the full product lifecycle, from early development through to lifecycle management

• Solid understanding of ICH guidelines and GxP environments, with the ability to translate these into practical, scalable processes

• Deep knowledge of EU regulatory frameworks, with additional exposure to US regulatory requirements considered highly advantageous

• Experience working with both biologics and small molecules, although flexibility can be considered depending on overall profile strength

• Proven leadership experience, particularly in leading leaders and driving organisational change and mindset transformation

• Experience operating as a system and people architect, building regulatory infrastructure and optimising ways of working

• Strong lifecycle management experience, at minimum at a regional level such as Europe, within a global context

• Excellent stakeholder management skills, with the ability to influence at senior leadership level

Why This Role

This is a high impact leadership role within an organisation that is actively evolving its regulatory function. It offers the opportunity to shape both the strategy and structure of Regulatory Affairs, while playing a critical role in advancing innovative therapies through development and into global markets.