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🥝 Sr Dir CMC Regulatory Affairs

Initial Therapeutics, Inc. | , , malaysia, Malaysia | Posted June 05, 2026

Job Description

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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