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⏰ Full-time

Sr Dir CMC Regulatory Affairs

Initial Therapeutics, Inc.
Location 📍 , , malaysia, Malaysia
Posted 📅 May 31, 2026
Work Type ⏰ Full-time

Position Overview

We are looking for a leader to guide our CMC & Combination Products regulatory team, supporting a global portfolio of drug and device products with a strong focus on the European Union. In this role, we work closely across functions to shape clear regulatory strategies that support development and keep submissions moving forward. You’ll play a central role in connecting teams, guiding decisions, and ensuring global regulatory alignment.

Typical Day

  • Leading a team delivering CMC and combination product regulatory activities
  • Shaping global regulatory strategies, with focus on EU requirements
  • Advising senior leaders on regulatory direction and key considerations
  • Overseeing submissions and resolving complex compliance issues
  • Working closely with regulators, partners, and external organisations
  • Monitoring new regulations and assessing impact on the portfolio
  • Improving processes and identifying more eff...

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Job Details

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