Regulatory Strategy Lead

4 days ago


Stevenage, Hertfordshire, United Kingdom Spur Therapeutics Full time
About This Role

The Sr. Director Regulatory CMC will play a critical role in overseeing the development and implementation of global regulatory CMC strategies for assigned Spur global gene therapy programs. This position requires strategic and operational leadership for regulatory CMC activities, interfacing with CMC, Clinical, and Clin Reg teams.

The ideal candidate will have at least 10 years' experience in CMC regulatory disciplines, preferably in a pharmaceutical or biotech company. Strong scientific background, excellent communication and interpersonal skills, and ability to work collaboratively in matrix teams are essential.

This is a hybrid role based at the Stevenage, UK or Boston, MA office location. The successful candidate will be responsible for developing CMC regulatory strategy, submission generation, submission reviews, and health authority interactions.



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