Submission Content Manager, Regulatory Affairs Operations

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.

Requirements

• Bachelor's degree
• Knowledge and experience of eCTD submissions
• Knowledge and experience with enterprise document management systems, preferably Veeva RIM
• Knowledge and understanding of global industry standards, guidelines, and validation concepts, including eCTD format and registration tracking
• Experience with StartingPoint eCTD templates or equivalent
• Minimum 3+ years pharmaceutical industry experience in Regulatory Affairs, Regulatory Operations or Medical Writing

Benefits

• Competitive compensation package
• Equity
• Bonus
• Benefits