Director of Regulatory Affairs

Job Summary

To support innovative oncology therapies, the full-time salaried Director of Regulatory Affairs will develop and execute regulatory strategies, ensuring compliance and timely product approvals while collaborating with cross-functional teams in a remote setting.

Key Responsibilities

• Develop and implement global regulatory strategies for clinical development and commercial programs, managing submissions
• Act as the primary liaison with regulatory agencies, overseeing communications, meetings, and inspections
• Provide strategic regulatory guidance to cross-functional teams and input on regulatory risk to leadership

Required Qualifications

• Advanced degree in life sciences, pharmacy, or related field preferred
• 10+ years of progressive experience in regulatory affairs within the biotechnology/pharmaceutical industry
• Minimum of 5 years experience in the hematology/oncology field
• Demonstrated track record of successful regulatory submissions and agency interactions
• Strong leadership abilities with 3+ years managing regulatory teams