Senior Manager, Global Regulatory Affairs Strategy

About this role

Olema Oncology is dedicated to developing better medicines for breast cancer and beyond. Our lead program, palazestrant (OP-1250), is a complete estrogen receptor antagonist (CERAN) currently in development for metastatic breast cancer with blockbuster potential as a monotherapy and in combination in ER+/HER2- metastatic breast cancer. Our follow-on product candidate, OP-3136, is a potent KAT6 inhibitor with best-in-class potential.


Our scientific breakthroughs are accelerated through the ways in which we fearlessly support, motivate, and challenge one another. At Olema, we know that when we put people first, our work becomes second to none. If you’re ready to join us at the edge of something unstoppable, let’s make a profound impact together for
our patients, for your career, for what’s beyond
.


You can view our latest corporate deck and other presentations here .


About the Role >>> Senior Manager, Global Regulatory Affairs Strategy
As the Senior Manager, Global Regulatory Affairs Strategy, reporting to the Senior Director, Global Regulatory Affairs Strategy, you will provide regulatory strategy support in partnership with cross functional teams and subject matter experts and manage regulatory aspects through all phases of development.


You will represent Regulatory Affairs on cross-functional teams, lead the planning and preparation of clinical trial submissions (INDs, CTAs, amendments, briefing documents, Investigator Brochures) and support global health authority interactions.


This role can be based out of our Boston, MA or San Francisco, CA office and will require domestic and international travel, approximately 10–15%


Your Work Will Primarily Encompass:

• With limited supervision, support the development and execution of global regulatory strategies for products in Olema’s pipeline, with a focus on early development and clinical trial applications
• Serve as the Regulatory Affairs representative on global project...