Associate Director, CMC Regulatory Affairs (Hematology/Oncology)

As an Associate Director you will lead the development and execution of global CMC regulatory strategies for the hematology and oncology portfolios. You will guide regulatory activities across development stages, mentor CMC Regulatory Affairs (RA) staff, supporting cross-functional and external partners, and serving as a key liaison in regulatory authority interactions.

For US locations, this role is on-site 4 days in the office and 1 day from home. For Uxbridge, UK or Dublin, Ireland this role would be on-site 3 days per week and 2 days from home. A fully remote role is not possible for this position . If eligible, we can offer relocation benefits.

A typical day may include the following: 
• Lead product development activities from a CMC regulatory standpoint with input from senior management.
• Represent CMC RA at program meetings and independently provide regulatory interpretation, position, and covering clinical development, initial market applications...