Associate Director, Regulatory Affairs

📋 Description

• Develop and execute U.S. and global regulatory strategies for assigned development programs.
• Collaborate with functional leaders to establish optimal clinical and regulatory development
• Help negotiate development strategies within cross-functional teams and with health authorities.
• Execute clinical-regulatory development plans on schedule while identifying and managing program
• Plan, manage, and prepare Clinical Trial Applications, Marketing Applications, and regulatory
• Ensure submission documents and regulatory correspondence meet high standards for content

🎯 Requirements

• Bachelor’s degree in life sciences required.
• Minimum of 5 years of regulatory affairs experience with a doctorate such as MD, PhD, PharmD, or
• Alternatively, 8 years of regulatory affairs experience with a master’s degree or 10 years with a
• Demonstrated experience supporting late-stage oncology drug development programs.
• Experience developing and negotiating clinical-regulatory strategies with health authorities
• Experience with the creation, submission, and negotiation of regulatory applications is preferred.

🎁 Benefits

• Salary: $185,000–$210,000 USD annual base salary.
• Work Model: Fully remote position.
• Career Scope: Leadership responsibility across U.S. and global regulatory strategies and
• Global Exposure: Opportunities to engage with regulatory authorities across North America, Europe
• Scientific Environment: Work involving innovative biologic development and novel cell and gene
• Cross-Functional Collaboration: Partner with clinical development and other functional leaders on