layiq
/la·yiq/adjective
worthy; deserving; fitting; suitable.
A role, opportunity, or path that merits attention, time, and pursuit.
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Job opportunity
Associate Director / Director, Regulatory Affairs - CMC
Iambic Therapeutics, Inc
San Diego, California, United States
Source: Iambic Therapeutics, Inc careers · View original posting
- Pay
- $164,000 — $245,000 USD per year
Employer job description
From Iambic Therapeutics, Inc's posting. “We” and “our” refer to the employer.
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. Level will be determined by education, depth of CMC regulatory experience, leadership, and scope of prior responsibilities.