Reporting to the Senior Vice President, Head of Global Regulatory Affairs, the Vice President (VP) of International Regulatory Affairs will be a leader and key member of the Global Regulatory Team and will be responsible for developing and implementing strategy and planning for global regulatory in territories beyond the US.
The VP will be responsible for hiring individuals to support establishment of the International regulatory team commensurate with company P5 x 25 goals and strategic priorities. In collaboration with their direct reports, the VP will identify the key strategic regulatory drivers for successful initial filings and for label expansions, supplemental applications/variations in markets beyond the US. The VP will ensure that product development strategies reflect the latest health authority requirements and thinking and enable adoption of novel regulatory approaches, as appropriate. This role will be required to present and defend regulatory global expansion plans to Senior Management.
The role will be based in Maidenhead, UK.