Tech Stack

Description

You will lead the development and submission of the NDA for the lead program and craft innovative global regulatory strategies across Olema's portfolio. Representing Regulatory Affairs on cross-functional teams, you will guide project teams, manage Health Authority interactions, and ensure compliance.

Requirements

• Bachelor's degree in scientific discipline required; advanced degree (Masters, PharmD, PhD) preferred
• Significant experience in regulatory affairs within pharmaceutical or biotech industry
• Experience leading NDA submissions and global regulatory strategies
• Strong knowledge of drug development and regulatory requirements
• Ability to travel up to 20% domestically and internationally

Responsibilities

• Lead NDA development and submission for lead program
• Develop and execute innovative global regulatory strategies
• Serve as Regulatory SME on cross-functional teams
• Represent Olema in Health Authority interactions
• Lead regulatory submissions (INDs, CTx, briefing documents, NDA, BLA, etc.)