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.

Location: Uxbridge
Work Mode: Hybrid (3 days per week on-site)

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, and approval/post-approval activities.
• Identify program issues and develop appropriate regulatory strategies to mit...