Associate Director, Global Regulatory Affairs Compliance
Olema Oncology
August 25, 2026
Remote friendly (Cambridge, MA)
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 for effective, compliant operations.
- 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:
- Bachelor’s degree in a scientific or related discipline; advanced degree preferred.
- 8+ years of Regulatory Affairs experience in pharma/biotech.
- Demonstrated ability to interpret and apply laws, regulations, and guidance.
- Required experience in technical and regulatory writing.
- Proven ability to independently plan, prioritize, and accomplish goals using sound judgment.
- Detail-oriented; able to manage multiple priorities and deadlines.
- Flexible/adaptable in a fast-paced environment.
- Strong interpersonal skills and collaboration across functions.
- Strong professional judgment with external experts and health authorities.
- Excellent written and verbal communication skills.
Skills/Attributes:
- Strong organizational, project management, and problem-solving skills.
- Excellent oral/written/presentation skills; proactive, self-starter; works independently and in teams.
Benefits/Pay:
- Base pay range: $190,000–$210,000 annually; total compensation may include equity, bonus, and benefits.
Work location/travel:
- Cambridge, MA or San Francisco, CA; onsite at least 2 days/week; ~10% travel.
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 for effective, compliant operations.
- 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:
- Bachelor’s degree in a scientific or related discipline; advanced degree preferred.
- 8+ years of Regulatory Affairs experience in pharma/biotech.
- Demonstrated ability to interpret and apply laws, regulations, and guidance.
- Required experience in technical and regulatory writing.
- Proven ability to independently plan, prioritize, and accomplish goals using sound judgment.
- Detail-oriented; able to manage multiple priorities and deadlines.
- Flexible/adaptable in a fast-paced environment.
- Strong interpersonal skills and collaboration across functions.
- Strong professional judgment with external experts and health authorities.
- Excellent written and verbal communication skills.
Skills/Attributes:
- Strong organizational, project management, and problem-solving skills.
- Excellent oral/written/presentation skills; proactive, self-starter; works independently and in teams.
Benefits/Pay:
- Base pay range: $190,000–$210,000 annually; total compensation may include equity, bonus, and benefits.
Work location/travel:
- Cambridge, MA or San Francisco, CA; onsite at least 2 days/week; ~10% travel.