Senior Director, Regulatory CMC

The successful candidate will be responsible for leading and managing the regulatory affairs within CMC function. This includes developing and leading regulatory CMC strategies and activities for a complex cell therapy product on a global basis. The successful candidate will ensure that all CMC regulatory goals are clearly defined and they align with current industry standards and regulatory requirements.

This role will also provide significant input on applicable regulatory affairs processes, procedures, and tools to facilitate effective execution by the regulatory function across the organization. This individual must be highly skilled and provide expertise in CMC agency interactions and developing regional regulatory CMC strategies.

In addition, the position assists corporate senior management in understanding CMC Regulatory strategies/processes while developing corporate objectives and, importantly, understanding the impact of decisions across therapeutic areas. Familiarity with GMP Quality, CMC development and exposure to clinical regulatory strategy is highly desired.

(***For the potential candidate at VP level direct report possibilities)