Associate Director, Global Regulatory Affairs Compliance

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

Associate Director, Global Regulatory Affairs Compliance

Supporting Olema's clinical development programs with a focus on breast cancer therapies.

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

Requirements

• Bachelor's degree in a scientific discipline (advanced degree preferred)
• 8+ years of regulatory affairs experience in pharma/biotech
• strong technical and regulatory writing skills
• proven ability to interpret complex regulations

High-Value

Focus on oncology (breast cancer), biologics and small molecules, primarily in Phase 3 development, supporting global filings, and working closely with cross-functional teams.

Work Setup

Hybrid in Cambridge, MA or San Francisco, CA; approximately 10% travel.