Senior Global Regulatory Affairs—Compliance & Strategy

Olema Pharmaceuticals, Inc.; San Francisco (CA); Hybrid; USD 190,000 - 210,000; Full time

Job summary

Olema Oncology seeks an Associate Director, Global Regulatory Affairs Compliance to advance development programs and ensure regulatory compliance across ind/submissions. Based in Cambridge, MA or San Francisco, CA, the role requires onsite presence and light travel.

Responsibilities include drafting and reviewing submissions, guiding regulatory strategy, and maintaining knowledge of 21 CFR parts and ICH guidelines. Collaboration with multiple functions is essential for success.

Qualifications

• Bachelor’s degree in a scientific discipline; advanced degree preferred.
• 8+ years of Regulatory Affairs experience in pharma/biotech.
• Experience in technical and regulatory writing.

Responsibilities

• Translate laws and guidance into regulatory strategies for compliance.
• Support timely execution of regulatory activities and milestones.
• Author regulatory submission documents and related correspondence.
• Review submissions for accuracy, completeness, and compliance.
• Develop and enhance regulatory policies, SOPs, and procedures.
• Provide support during regulatory and quality inspections.
• Maintain current knowledge of relevant regulations and ICH guidelines.

Skills

Regulatory strategy

Regulatory writing

Cross-functional collaboration

Regulatory submissions

Communication (written and verbal)

Regulatory inspections

Attention to detail

Education

Bachelor’s degree in science or related field

Advanced degree preferred

Job description

Olema Oncology seeks an Associate Director, Global Regulatory Affairs Compliance to advance development programs and ensure regulatory compliance across ind/submissions. Based in Cambridge, MA or San Francisco, CA, the role requires onsite presence and light travel.

Responsibilities include drafting and reviewing submissions, guiding regulatory strategy, and maintaining knowledge of 21 CFR parts and ICH guidelines. Collaboration with multiple functions is essential for success.