Global Regulatory Affairs Compliance Lead

Olema Oncology; Cambridge (MA); Hybrid; USD 190,000 - 210,000; Full time

Benefits offered by this job

Equity

Bonus

Benefits

Job summary

Olema Oncology is seeking an Associate Director, Global Regulatory Affairs Compliance, to advance regulatory strategies across its lead and follow‑on programs. Based in Cambridge, MA or San Francisco, CA, you will partner cross‑functionally to ensure compliant submissions and timely milestones.

You will manage INDs, NDAs, and health authority materials, contribute to technical writing, and maintain current knowledge of global regulations.

Qualifications

• Bachelor’s degree in a scientific or related discipline; an advanced degree is preferred.
• 8+ years of Regulatory Affairs experience within the pharmaceutical or biotechnology industry.
• Demonstrated ability to interpret and apply applicable laws, regulations, and regulatory guidance.

Responsibilities

• Translate applicable laws, regulations, and guidance into practical regulatory strategies that support development programs and business objectives.
• Support high‑quality, timely execution of regulatory activities, deliverables, and milestones.
• Author and contribute to regulatory submission documents, including INDs, NDAs, health authority materials and related correspondence.
• Review regulatory submissions for accuracy, consistency, completeness, and compliance.
• Develop and enhance regulatory policies, procedures, and SOPs for compliant operations.
• Provide regulatory expertise and documentation support during regulatory and quality inspections.
• Maintain current knowledge of pharmaceutical development concepts, practices, and regulatory requirements, including 21 CFR parts 50, 54, 56, 200, 201, 202, 207, 312, 314 and relevant ICH guidelines.

Skills

Regulatory affairs

Technical writing

Cross-functional collaboration

Regulatory strategy

Regulatory inspections

Education

Bachelor’s degree in a scientific or related discipline

Advanced degree preferred

Job description

Olema Oncology is seeking an Associate Director, Global Regulatory Affairs Compliance, to advance regulatory strategies across its lead and follow‑on programs. Based in Cambridge, MA or San Francisco, CA, you will partner cross‑functionally to ensure compliant submissions and timely milestones.

You will manage INDs, NDAs, and health authority materials, contribute to technical writing, and maintain current knowledge of global regulations.