Long Description
We are seeking a highly experienced Director CMC Regulatoryto drive the global strategy for small molecule assets within a fast-growing, innovation-driven environment. This is a high-impact, senior role with strategic visibility and the opportunity to shape a strong development pipeline.This position reports directly to the Head of Small Molecule Development within Regulatory CMC.
Key Focus:While early-stage exposure is valued, deep expertise in late-stage development and preparation for global Marketing Authorisation submissions is essential. We are looking for someone who has successfully guided assets through the final phases of development to approval.
Key Responsibilities:
Lead and own the global CMC Regulatory strategy for advanced-stage development assets
Drive high-quality, timely regulatory submissions and agency interactions
Partner closely with CMC technical functions, Quality Assurance, Supply Chain, and senior leadership
Ensure regulatory strategies enable accelerated development pathways and efficient product delivery
Profile:We are seeking a seasoned CMC Regulatory professional (15+ years) with a strong track record in late-stage development and global submissions for small molecule assets. You bring strategic depth, scientific rigor, leadership maturity, and the ability to thrive in a dynamic, high-ambition environment.
If you bring proven late-stage CMC leadership and are motivated to shape impactful development programs, we would welcome a conversation.
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