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Associate Director, CMC Regulatory Affairs (Hematology/Oncology)

Company

Initial Therapeutics, Inc.

Location

, , malaysia, Malaysia

Type

Full-time

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.

Location & Travel

This is a Dublin, Ireland based position and requires you to be on‑site three days per week and two days from home. A fully remote role is not possible for this position. If eligible, relocation benefits may be offered.

Key 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, position, and cover clinical development, initial market applications, and approval/post‑approval activities.

Identify program...

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