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⏰ Full-time

Associate Director, CMC Regulatory Affairs (Hematology/Oncology)

BioSpace
Location 📍 kuah, Malaysia
Posted 📅 June 15, 2026
Work Type ⏰ Full-time

Position Overview

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

Where And When

This is a Dublin, Ireland based position and you 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.

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 approval/post‑approval act...

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Job Details

Employment Type
Full-time
📊
Category
Management & Operations
🏠
Work Arrangement
On-site
📍
Location
kuah, Malaysia