Global Regulatory Lead – Oncology (Hybrid)

Olema Oncology; San Francisco (CA); Hybrid; USD 180,000 - 240,000; Full time

Job summary

Olema Oncology is seeking an Associate Director, Global Regulatory Affairs Compliance to lead regulatory strategies for its oncology programs, with a focus on breast cancer therapies. You will translate regulations into practical compliance actions and ensure accuracy across IND/NDA submissions while supporting regulatory inspections.

The role emphasizes collaboration with cross-functional teams, advancing Phase 3 development, and global filings.

Qualifications

• 8+ years of regulatory affairs experience in pharma/biotech.
• Strong technical and regulatory writing skills.
• Ability to interpret complex regulations and guidance.

Responsibilities

• Developing and implementing regulatory strategies.
• Ensuring compliance across submissions such as INDs, NDAs, and regulatory communications.
• Supporting regulatory and quality inspections.
• Translating laws and guidance into practical compliance measures.
• Reviewing regulatory documents for accuracy.
• Enhancing policies and procedures.

Skills

Regulatory strategy

Regulatory writing

Regulatory interpretation

Cross-functional collaboration

Education

Bachelor's degree in a scientific discipline (advanced degree preferred)

Job description

Olema Oncology is seeking an Associate Director, Global Regulatory Affairs Compliance to lead regulatory strategies for its oncology programs, with a focus on breast cancer therapies. You will translate regulations into practical compliance actions and ensure accuracy across IND/NDA submissions while supporting regulatory inspections.

The role emphasizes collaboration with cross-functional teams, advancing Phase 3 development, and global filings.