Associate Director, Global Regulatory Affairs, Compliance and Project Management

The role

You will manage projects to advance development programs and oversee all regulatory compliance activities. You will partner cross-functionally to implement strategies for regulatory submissions and operational activities.

What you will do

• Translate applicable laws, regulations, and guidance for managing regulatory projects.
• Implement regulatory strategies supporting compliance for development programs.
• Support high-quality, timely execution of regulatory activities and milestones.
• Interact with cross functional project teams to manage and track regulatory activities.
• Communicate identified risks to compliance of regulatory submission documents.
• Manage timelines for all regulatory milestones across projects.
• Provide remedial actions to identified risks across projects.
• Review regulatory submissions for accuracy, consistency, completeness, and compliance.
• Develop and enhance regulatory policies, procedures, and SOPs.
• Provide regulatory expertise and documentation support during regulatory and quality inspections.

Required qualifications

• Bachelor’s degree in a scientific or related discipline
• 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
• String interpersonal skills to work with cross functional project teams
• Required experience in technical and regulatory writing
• Ability to independently plan, prioritize, and accomplish goals using sound judgment
• Detail-oriented and highly organized
• 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
• Excellent written and verbal communication skills

Nice to have

• Advanced degree
• Project Management (PMP) Certification

Benefits

• Equity
• Bonus
• Benefits

About the company

Olema Oncology is a clinical-stage biopharmaceutical company committed to transforming the standard of care and improving outcomes for patients living with breast cancer and beyond.