Associate Director, Global Regulatory Affairs, Compliance and Project Management 

About the Role >>> Associate Director, Global Regulatory Affairs, Compliance and Project Management 

As the Global Associate Director, Regulatory Affairs, compliance and project management reporting to the Senior Director, Global Regulatory Strategy, you will play a key role in the managing projects designed towards advancing Olema’s development programs and helping bring innovative therapies to patients.  The role involves oversight of all regulatory compliance activities. You will partner cross-functionally to manage the projects of all Olema assets in development and post approval.  Implement strategies to ensure compliance with applicable laws, regulations, and guidance documents for regulatory submissions and regulatory operational activities.  

You will support managing all projects with adherence to compliance of high-quality regulatory submissions—including INDs, NDAs, health authority meeting materials, and other key documents—and contribute to the regulatory and technical writing required throughout the product development lifecycle. 

This position is based in our Cambridge, MA, or San Francisco, CA office. The role requires approximately 10% travel. 

Your work will primarily encompass: 

• Translate applicable laws, regulations, and guidance for managing regulatory projects. 
• Implement regulatory strategies supporting compliance that support development programs and business objectives. 
• Supporting the high-quality, timely execution of regulatory activities, deliverables, and milestones. 
• Interact with cross functional project teams to manage and track all regulatory activities and communicate any identified risks to wards compliance of regulatory submission documents, including INDs, NDAs, health authority meeting materials, and related correspondence. 
• Manage the timelines for all regulatory milestones across projects and support regulatory operations for tracking and maintaining submission timelines. 
• Provide remedial actions to any identified risks across projects including any unforeseen situations that can delay or hinder project continuity 
• 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. 

Ideal Candidate Profile >>> Regulatory Compliance Project Management 

A love of challenging, important work. We are a pragmatic team, driven to imagine and develop meaningful therapies for improving lives. All employees within our company play a unique and crucial role in our success, both in accomplishing our mission and building a positive company culture. As such, we are looking for someone with the right combination of knowledge, experience, and attributes for this role. 

Experience: 

• Bachelor’s degree in a scientific or related discipline; an advanced degree is preferred. 
• 8+ years of Regulatory Compliance and Project Management experience within the pharmaceutical or biotechnology industry. 
• Demonstrated skills to interpret and apply applicable laws, regulations, and regulatory guidance to manage compliance. 
• String interpersonal skills with the ability to work with cross functional project teams. 
• 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. 
• Flexible and adaptable to thrive in a dynamic, fast-paced environment. 
• Sound professional judgment when interacting with external experts, health authorities, and other key stakeholders. 
• Project Management (PMP) Certification preferred. 
• Excellent written and verbal communication skills. 

Attributes: 

• Strong organizational, project management, and problem-solving skills 
• Excellent oral, written, and presentation skills 
• Flexible and proactive, with the ability to manage multiple projects and adapt to changing priorities 
• Self-starter with the ability to work both independently and within teams 

The base pay range for this position is expected to be $185,000 - $205,000 annually, however the base pay offered may vary depending on location, market, job related knowledge, skills and capabilities, and experience. The total compensation package for this position also includes equity, bonus, and benefits.

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