Global Regulatory Strategy Director

Olema Oncology; San Francisco (CA); On-site; USD 230,000 - 250,000; Full time

Benefits offered by this job

Equity

Bonus

Benefits

Job summary

Olema Oncology is seeking a Director, Global Regulatory Strategy Lead to drive regulatory direction for key oncology programs. Lead global strategy development, guide submissions, and collaborate across teams while interfacing with health authorities.

Ideal candidate has 12+ years in Regulatory Affairs, strong leadership, and oncology experience, with travel up to 20% and on-site presence in Boston or San Francisco.

Qualifications

• Bachelor's degree in a scientific discipline.
• 12+ years in Regulatory Affairs in Pharma/Biotech.
• Minimum of 3 years direct leadership experience.
• Experience in Oncology Therapeutic area preferred.
• Strong negotiation with health authorities (FDA/EMA) and submissions (IND/CTx to NDA/BLA).

Responsibilities

• Lead the development of global regulatory strategies for Olema assets.
• Develop and execute regulatory submissions (INDs, NDA/BLA, DMFs, IMPDs).
• Represent Regulatory Affairs on cross-functional teams as SME.
• Interact with health authorities to advance program objectives.
• Mentor and lead regulatory team(s) to achieve company goals.

Skills

Regulatory strategy

Leadership

Cross-functional collaboration

FDA/EMA negotiations

Oncology experience

Regulatory submissions

Education

Bachelor degree in scientific discipline

Advanced degree (Masters/PhD/ PharmD) preferred

Tools

Veeva

Job description

Olema Oncology is seeking a Director, Global Regulatory Strategy Lead to drive regulatory direction for key oncology programs. Lead global strategy development, guide submissions, and collaborate across teams while interfacing with health authorities.

Ideal candidate has 12+ years in Regulatory Affairs, strong leadership, and oncology experience, with travel up to 20% and on-site presence in Boston or San Francisco.