Associate Director, Regulatory Affairs CMC
Olema Oncology(20 days ago)
About this role
As the Associate Director, Regulatory Affairs CMC at Olema Oncology, you will be responsible for developing and executing CMC regulatory strategies for the company's product(s) in development and post-approval. This role requires aligning strategies with Health Authority requirements globally and guiding cross-functional teams to ensure high quality and timely submissions.
Required Skills
- Regulatory Affairs
- CMC Strategies
- Clinical Trials
- Compliance
- Cross-Functional Collaboration
Qualifications
- Bachelor's Degree
About Olema Oncology
olema.comOlema Oncology is a cancer medicines company focused on innovating therapies for breast cancer and other endocrine-driven tumors. The company is rapidly advancing a pipeline of drug candidates designed to target the biology of endocrine-driven disease. Olema’s work centers on translating cutting‑edge science into treatments that meaningfully impact patients, progressing programs toward clinical evaluation.
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