Global Regulatory Strategy Director

Olema Oncology; Boston (MA); On-site; USD 230,000 - 250,000; Full time

Job summary

Olema Oncology seeks a Director, Global Regulatory Strategy Lead to guide innovative regulatory strategies across its oncology portfolio. Based in Boston or San Francisco, you will lead cross-functional teams, oversee submissions (INDs, NDA/BLA), and partner with global health authorities to drive product development and lifecycle plans.

You will mentor a growing Regulatory Affairs group, ensure regulatory compliance, and coordinate global submissions while staying ahead of evolving HA policies.

Qualifications

• Bachelor’s degree in a scientific discipline required.
• Advanced degree (MS/PhD/PharmD) preferred.
• 12+ years regulatory affairs in Pharma/Biotech.
• Minimum 3 years direct leadership experience.
• Oncology experience strongly preferred.
• Strong negotiation with health authorities and experience with IND/CTx to NDA/BLA submissions.
• Able to operate in a fast-paced environment with multiple projects.
• Excellent oral, written, and presentation skills.

Responsibilities

• Lead global regulatory strategy development for Olema assets and lifecycle.
• Develop and oversee regulatory submissions (INDs, CTX, NDA/BLA, etc.).
• Represent Regulatory Affairs on cross-functional teams as SME.
• Stay updated on regulatory landscapes and HA requirements.
• Coordinate HA reporting schedules with cross-functional teams.
• Lead agency interactions to achieve company objectives.
• Identify gaps and implement risk mitigation for submissions.
• Mentor regulatory colleagues and ensure department compliance.
• Travel domestically/internationally up to 20%.

Skills

Regulatory Leadership

Regulatory Strategy

Cross-functional Leadership

IND/CTA/NDA Knowledge

Education

Bachelor’s degree in a scientific discipline

Advanced degree (MS/PhD/PharmD)

Tools

Veeva

Regulatory submissions tools

Job description

Olema Oncology seeks a Director, Global Regulatory Strategy Lead to guide innovative regulatory strategies across its oncology portfolio. Based in Boston or San Francisco, you will lead cross-functional teams, oversee submissions (INDs, NDA/BLA), and partner with global health authorities to drive product development and lifecycle plans.

You will mentor a growing Regulatory Affairs group, ensure regulatory compliance, and coordinate global submissions while staying ahead of evolving HA policies.