Global Regulatory Compliance Leader

Olema Oncology; San Francisco (CA); Hybrid; USD 190,000 - 210,000; Full time

Benefits offered by this job

Equity

Bonus

Benefits package

Job summary

Olema Oncology seeks an experienced Global Regulatory Affairs Compliance Associate Director to advance regulatory strategies across our development programs. You will partner cross-functionally to ensure compliance with laws, regulations, and guidance, and manage high-quality submissions (INDs, NDAs, health authority materials).

The role is based in Cambridge, MA or San Francisco, CA, with onsite expectation two days per week and about 10% travel.

Qualifications

• Bachelor’s degree in a scientific or related discipline; advanced degree 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.
• Required experience in technical and regulatory writing.
• Proven ability to independently plan, prioritize, and accomplish goals using sound judgment.
• Detail-oriented and highly organized, with the ability to manage multiple priorities and deadlines.
• Excellent written and verbal communication skills and ability to collaborate across functions.

Responsibilities

• Translate applicable laws, regulations, and guidance into practical regulatory strategies supporting compliance that support development programs and business objectives.
• Supporting the high-quality, timely execution of regulatory activities, deliverables, and milestones.
• Author and contribute to compliance of regulatory submission documents, including 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 that support effective and 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 applicable provisions of 21 CFR Parts 50, 54, 56, 200, 201, 202, 207, 312, and 314, as well as relevant ICH guidelines.

Skills

Regulatory strategy

Regulatory writing

Cross-functional collaboration

Regulatory compliance

Project management

Detail-oriented

Education

Bachelor's degree

Advanced degree preferred

Job description

Olema Oncology seeks an experienced Global Regulatory Affairs Compliance Associate Director to advance regulatory strategies across our development programs. You will partner cross-functionally to ensure compliance with laws, regulations, and guidance, and manage high-quality submissions (INDs, NDAs, health authority materials).

The role is based in Cambridge, MA or San Francisco, CA, with onsite expectation two days per week and about 10% travel.