Director, Global Regulatory Lead - Oncology

The Director, Global Regulatory Lead - Oncology will oversee and execute all regulatory activities of one or multiple complex projects in development and/or support regulatory activities for assigned projects. The role will serve as the primary FDA contact for projects of responsibility and be accountable for all US FDA submissions and approvals of project(s) of responsibility.

Requirements

• Bachelor’s Degree required, scientific discipline strongly preferred, advanced degree in a scientific discipline strongly preferred.
• A minimum of 8 years of pharmaceutical industry experience, inclusive of regulatory and/or related experience.
• Solid working knowledge of drug development process and regulatory requirements.
• Experience in managing major regulatory filing(s); and experience as a significant contributor to regulatory and/or development strategies.

Benefits

• Medical, dental, vision insurance
• 401(k) plan and company match
• Short-term and long-term disability coverage
• Basic life insurance
• Tuition reimbursement program
• Paid volunteer time off
• Company holidays
• Well-being benefits
• Up to 80 hours of sick time
• Up to 120 hours of paid vacation