Associate Director, Global Regulatory Affairs Compliance
Olema Oncology
August 25, 2026
Remote friendly (Boston, MA)
United States
Corporate Functions
Associate Director, Global Regulatory Affairs, Compliance
Responsibilities:
- Translate applicable laws, regulations, and guidance into practical regulatory compliance strategies supporting development 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 for compliant operations.
- Provide regulatory expertise and documentation support during regulatory and quality inspections.
- Maintain current knowledge of pharmaceutical development concepts and regulatory requirements, including relevant 21 CFR Parts and ICH guidelines.
Qualifications / Preferred Experience:
- Bachelor’s degree in a scientific or related discipline; advanced degree preferred.
- 8+ years of Regulatory Affairs experience in pharmaceutical/biotechnology.
- Demonstrated ability to interpret and apply applicable laws, regulations, and guidance.
- Required: technical and regulatory writing experience.
Skills/Attributes:
- Independently plan/prioritize using sound judgment; detail-oriented; manage multiple priorities/deadlines.
- Strong interpersonal skills; collaborate cross-functionally; sound judgment with external stakeholders.
- Excellent written/verbal communication; strong organizational/project management/problem-solving.
- Flexible, proactive self-starter; works independently and in teams.
Compensation/Benefits (as stated): Base pay range expected $190,000–$210,000 annually; total compensation may include equity, bonus, and benefits.
Responsibilities:
- Translate applicable laws, regulations, and guidance into practical regulatory compliance strategies supporting development 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 for compliant operations.
- Provide regulatory expertise and documentation support during regulatory and quality inspections.
- Maintain current knowledge of pharmaceutical development concepts and regulatory requirements, including relevant 21 CFR Parts and ICH guidelines.
Qualifications / Preferred Experience:
- Bachelor’s degree in a scientific or related discipline; advanced degree preferred.
- 8+ years of Regulatory Affairs experience in pharmaceutical/biotechnology.
- Demonstrated ability to interpret and apply applicable laws, regulations, and guidance.
- Required: technical and regulatory writing experience.
Skills/Attributes:
- Independently plan/prioritize using sound judgment; detail-oriented; manage multiple priorities/deadlines.
- Strong interpersonal skills; collaborate cross-functionally; sound judgment with external stakeholders.
- Excellent written/verbal communication; strong organizational/project management/problem-solving.
- Flexible, proactive self-starter; works independently and in teams.
Compensation/Benefits (as stated): Base pay range expected $190,000–$210,000 annually; total compensation may include equity, bonus, and benefits.