About the job
At Olema Oncology, we are committed to pioneering innovative treatments for breast cancer and beyond. Our flagship program, palazestrant (OP-1250), is a revolutionary complete estrogen receptor antagonist (CERAN) currently under development for metastatic breast cancer, showcasing significant potential as both a standalone treatment and in combination therapies for ER+/HER2- metastatic breast cancer. Additionally, our next product candidate, OP-3136, is a potent KAT6 inhibitor with the potential to be best-in-class.
Our scientific achievements are driven by a culture of fearless support, motivation, and challenge amongst our team members. At Olema, we believe that prioritizing our people translates into unparalleled work. If you are eager to be part of an unstoppable force and make a substantial impact on patients' lives, your career, and the future, let’s unite in this mission.
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Position Overview: Associate Director, Regulatory Affairs CMC
In the role of Associate Director of Regulatory Affairs CMC, you will report to the Senior Director of Regulatory Affairs CMC. Your main responsibilities will include developing and executing comprehensive CMC regulatory strategies for Olema’s products throughout their development and post-approval phases. You will ensure these strategies are in compliance with global Health Authority requirements and provide guidance and oversight for producing high-quality, timely CMC sections of regulatory submissions. Furthermore, you will offer CMC regulatory strategy support to cross-functional teams within the organization.
This position is based in our San Francisco, CA office and will require approximately 10% travel.
Your Responsibilities Will Include:
- Providing CMC regulatory expertise for global development and registration programs (e.g., INDs, CTAs, BLAs, and MAAs).
- Supporting regulatory agency interactions to ensure alignment on CMC strategies for initial INDs/CTAs, marketing registration applications, supplements, and variations.
- Offering CMC support for the global regulatory plan, development plans, clinical study designs, and risk assessments.
- Proactively communicating critical issues and potential mitigations to teams, senior management, and key stakeholders in a timely manner.
- Assessing and conveying regulatory requirements to ensure compliance with applicable regulations and guidelines throughout development activities.
- Managing and ensuring compliance with all reporting requirements.