Temporary Regulatory Affairs Director

Job Summary

Temporary Regulatory Affairs Director, a contract position requiring extensive regulatory affairs experience, leads regulatory intelligence collection and analysis, ensuring compliance and process improvement while collaborating with cross-functional teams.

Key Responsibilities

• Lead the collection and dissemination of regulatory intelligence to inform policies and practices
• Develop and execute regulatory impact assessments and action plans for compliance
• Monitor regulatory environments and communicate findings to stakeholders and leadership

Required Qualifications

• Bachelor's degree with 13 years of experience, master's degree with 11 years, or PhD with 8 years in a related discipline
• Regulatory Affairs and oncology experience within a pharmaceutical company
• Extensive knowledge of regulatory frameworks and industry practices
• Proven leadership of cross-functional teams and collaboration skills
• Knowledge of regulatory systems, compliance standards, and audit processes