Global Regulatory Compliance Director (Associate)

Olema Pharmaceuticals, Inc.; Northern (KY); Hybrid; USD 190,000 - 210,000; Full time

Job summary

Olema Pharmaceuticals, Inc. is seeking an Associate Director, Global Regulatory Affairs Compliance to lead regulatory strategies and writing across development programs.

You will partner with multiple functions to ensure compliant submissions and documentation throughout the product lifecycle. The role is based in Cambridge, MA or San Francisco, CA, onsite at least two days per week, with roughly 10% travel.

Qualifications

• Bachelor's degree in a scientific field; advanced degree preferred.
• 8+ years of Regulatory Affairs experience in pharma/biotech.
• Experience in technical and regulatory writing.
• Ability to plan, prioritize, and meet deadlines.
• Strong collaboration across functions.

Responsibilities

• Translate applicable laws into practical regulatory strategies supporting compliance and development goals.
• Support high-quality, timely execution of regulatory activities, deliverables, and milestones.
• Author and contribute to regulatory submission documents and related correspondence.
• Review regulatory submissions for accuracy, completeness, and compliance.
• Maintain current knowledge of regulatory requirements and ICH guidelines.

Skills

Regulatory strategy

Regulatory writing

Cross-functional collaboration

Regulatory interpretation

Attention to detail

Education

Bachelor's degree in science

Advanced degree preferred

Job description

Olema Pharmaceuticals, Inc. is seeking an Associate Director, Global Regulatory Affairs Compliance to lead regulatory strategies and writing across development programs.

You will partner with multiple functions to ensure compliant submissions and documentation throughout the product lifecycle. The role is based in Cambridge, MA or San Francisco, CA, onsite at least two days per week, with roughly 10% travel.