Associate Director, CMC Regulatory Affairs (Hematology/Oncology)

Build our future together:

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.

Where and when:

This is a Dublin, Ireland based position and would you to 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.

Discover your role:

• 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, and ap...