Associate Director, Global Regulatory Affairs, Compliance and Project Management

The role

The Associate Director manages projects to advance development programs and oversees regulatory compliance activities. This role involves implementing strategies to ensure compliance with laws and regulations 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 regulatory activities and communicate risks.
• 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.