Global Regulatory Compliance Lead

Olema Oncology; Boston (MA); Hybrid; USD 190,000 - 210,000; Full time

Benefits offered by this job

Equity

Bonus

Benefits package

Job summary

Olema Oncology in Cambridge, MA or San Francisco, CA is seeking an Associate Director, Global Regulatory Affairs, Compliance to lead regulatory strategies, ensure compliance across programs, and coordinate with cross-functional teams to advance palazestrant and OP-3136 through INDs and NDAs.

You will craft high-quality submissions, maintain knowledge of 21 CFR parts and ICH guidelines, supervise writing, and support inspections; this hybrid role requires onsite presence two days per week and

Qualifications

• Bachelor’s degree in a scientific or related discipline (required).
• Advanced degree is preferred.
• Proven ability to interpret and apply applicable laws, regulations, and regulatory guidance.
• Required experience in technical and regulatory writing.
• Strong planning, prioritization, and judgment skills.
• Detail-oriented and highly organized with the ability to manage multiple priorities.
• Flexible and adaptable in a fast-paced environment.
• Strong interpersonal and cross-functional collaboration skills.
• Excellent written and verbal communication skills.

Responsibilities

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

Skills

Regulatory affairs

Technical writing

Regulatory submissions

Cross-functional collaboration

Regulatory strategy

Communication skills

Project management

Attention to detail

Leadership

Education

Bachelor’s degree in a scientific discipline

Advanced degree preferred

Job description

Olema Oncology in Cambridge, MA or San Francisco, CA is seeking an Associate Director, Global Regulatory Affairs, Compliance to lead regulatory strategies, ensure compliance across programs, and coordinate with cross-functional teams to advance palazestrant and OP-3136 through INDs and NDAs.

You will craft high-quality submissions, maintain knowledge of 21 CFR parts and ICH guidelines, supervise writing, and support inspections; this hybrid role requires onsite presence two days per week and