Director CMC Regulatory Affairs (M/F)

Long Description We are seeking a highly experienced Director CMC Regulatory to 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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