Associate Director, CMC Regulatory Affairs (Hematology/Oncology)

Position Overview

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 staff, support cross‑functional and external partners, and serve as a key liaison in regulatory authority interactions.

This Uxbridge based role requires on‑site presence 3 days per week and remote work 2 days per week. Remote work is not feasible. Relocation benefits may be offered if eligible.

Responsibilities

• 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, positioning, and support across clinical development, initial market applications, and approval/post‑approval activities.
• Identify program issues and develop appropriate reg...