Submission Content Manager, Regulatory Affairs Operations

Olema Oncology is dedicated to developing better medicines for breast cancer and beyond. The company is seeking a Submission Content Manager, Regulatory Affairs Operations, to prepare regulatory submission documents for final publishing and delivery to global health authorities.

Requirements

• Bachelor's degree is required
• Minimum 3+ years pharmaceutical industry experience in Regulatory Affairs, Regulatory Operations or Medical Writing
• Knowledge and experience of eCTD submissions
• Knowledge and experience with enterprise document management systems, preferably Veeva RIM
• Experience with StartingPoint eCTD templates or equivalent
• Demonstrated leadership skills while working in a fast paced and changing environment

Benefits

• Competitive compensation package
• Equity
• Bonus
• Benefits