Associate Director / Director, Regulatory Affairs - CMC
director$164K – $245K
via Ashby
About this role
JOB SUMMARY
The Associate Director/Director of Regulatory Affairs - Chemistry, Manufacturing and Controls (CMC) will lead global CMC regulatory strategy and execution across Iambic's development programs. The role will prepare and oversee high-quality CMC content for regulatory submissions, provide phase-appropriate regulatory guidance, identify and mitigate risks, and ensure alignment with program objectives and global requirements. This individual will partner closely with Technical Operations, Process Chemistry, Analytical Development, Formulation, Manufacturing, Quality, Clinical, Nonclinical, Regulatory Operations, and external partners, and will support interactions with the US FDA and other global health authorities as appropriate.…
What we'd score you on
reqspace match rubricFive dimensions, recruiter-grade. Upload your resume and we'll generate a written explanation of where you fit and where the gaps are.
1
Skills match
We compare your skills against the role requirements.
2
Level fit
This role is director-level. We check your trajectory against it.
3
Domain experience
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4
Recency
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5
Location fit
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Free · no card · written explanation included