Associate Director, Global Regulatory Affairs Compliance
Olema Oncology
August 25, 2026
Remote friendly (San Francisco, CA)
United States
Corporate Functions
Associate Director, Global Regulatory Affairs, Compliance
Responsibilities:
- Translate applicable laws, regulations, and guidance into practical regulatory strategies supporting compliance and business objectives.
- Support high-quality, timely execution of regulatory activities, deliverables, and milestones.
- Author and contribute to compliance of regulatory submission documents (INDs, NDAs, health authority meeting materials) and related correspondence.
- Review regulatory submissions for accuracy, consistency, completeness, and compliance.
- Develop and enhance regulatory policies, procedures, and SOPs.
- Provide regulatory expertise and documentation support during regulatory and quality inspections.
- Maintain current knowledge of pharmaceutical development concepts and regulatory requirements (including 21 CFR Parts 50, 54, 56, 200, 201, 202, 207, 312, 314) and relevant ICH guidelines.
Qualifications (Required/Preferred):
- Bachelor’s degree in scientific/related discipline; advanced degree preferred.
- 8+ years of Regulatory Affairs experience in pharma/biotech.
- Demonstrated ability to interpret/apply laws, regulations, and regulatory guidance.
- Required: technical and regulatory writing experience.
Skills/Attributes:
- Independently plan/prioritize and use sound judgment.
- Detail-oriented, highly organized; manage multiple priorities/deadlines.
- Strong interpersonal skills; collaborate across functions.
- Excellent written/verbal communication; strong oral/presentation skills.
- Flexible, proactive self-starter; able to work independently and in teams.
Comp/Benefits (if applicable): Base pay range expected $190,000–$210,000 annually; total compensation includes equity, bonus, and benefits.
Responsibilities:
- Translate applicable laws, regulations, and guidance into practical regulatory strategies supporting compliance and business objectives.
- Support high-quality, timely execution of regulatory activities, deliverables, and milestones.
- Author and contribute to compliance of regulatory submission documents (INDs, NDAs, health authority meeting materials) and related correspondence.
- Review regulatory submissions for accuracy, consistency, completeness, and compliance.
- Develop and enhance regulatory policies, procedures, and SOPs.
- Provide regulatory expertise and documentation support during regulatory and quality inspections.
- Maintain current knowledge of pharmaceutical development concepts and regulatory requirements (including 21 CFR Parts 50, 54, 56, 200, 201, 202, 207, 312, 314) and relevant ICH guidelines.
Qualifications (Required/Preferred):
- Bachelor’s degree in scientific/related discipline; advanced degree preferred.
- 8+ years of Regulatory Affairs experience in pharma/biotech.
- Demonstrated ability to interpret/apply laws, regulations, and regulatory guidance.
- Required: technical and regulatory writing experience.
Skills/Attributes:
- Independently plan/prioritize and use sound judgment.
- Detail-oriented, highly organized; manage multiple priorities/deadlines.
- Strong interpersonal skills; collaborate across functions.
- Excellent written/verbal communication; strong oral/presentation skills.
- Flexible, proactive self-starter; able to work independently and in teams.
Comp/Benefits (if applicable): Base pay range expected $190,000–$210,000 annually; total compensation includes equity, bonus, and benefits.