About the role
At Olema Oncology, we are committed to revolutionizing the treatment of breast cancer and beyond. Our flagship program, palazestrant (OP-1250), is a complete estrogen receptor antagonist (CERAN) that is currently being developed for metastatic breast cancer, showcasing blockbuster potential both as a standalone therapy and in combination with other treatments for ER+/HER2- metastatic breast cancer. Additionally, we are advancing our follow-on candidate, OP-3136, a powerful KAT6 inhibitor with the potential to be a market leader.
We believe that our scientific advancements are fueled by a culture of fearless support, motivation, and challenge among our team members. At Olema, when we prioritize our people, our work achieves unparalleled excellence. If you are eager to be part of something transformative, let’s work together to make a significant impact for our patients, your career, and the future of medicine.
For more insights, please check our latest corporate presentations here.
About the Role: Associate Director, Regulatory Affairs CMC
In your role as Associate Director of Regulatory Affairs CMC, you will report directly to the Senior Director of Regulatory Affairs CMC. Your primary responsibility will be to develop and implement CMC regulatory strategies for Olema’s product pipeline, both in development and post-approval stages. You will ensure alignment with global Health Authority requirements and provide guidance and oversight to facilitate the development of high-quality, timely CMC sections within regulatory submissions. Furthermore, you will offer CMC regulatory strategy support and advice to cross-functional teams throughout the organization.
This position is based in our Boston, MA office and requires approximately 10% travel.
Your responsibilities will include:
- Offering CMC regulatory expertise across global development and registration initiatives (e.g., INDs, CTAs, BLAs, and MAAs).
- Facilitating agency interactions to ensure alignment on CMC strategies for initial INDs/CTAs, marketing registration applications, supplements, and variations.
- Providing CMC support for the global regulatory plan, development plans/clinical study designs, and risk assessments.
- Communicating critical issues and potential mitigations effectively and promptly with teams, senior management, and key stakeholders.
- Assessing and communicating regulatory requirements to ensure compliance with relevant regulations and guidelines.
- Managing and ensuring adherence to all reporting requirements.

