Job Description

Associate Director leading regulatory strategy and submissions for drug development programs across US and global markets. The role emphasizes clinical development strategies, health authority interactions, and regulatory expertise in biologic and cell therapy products for oncology.

Responsibilities

• Lead one or more drug development programs with focus on US and global regulatory strategy
• Plan, manage, and create clinical trial applications, market applications, and regulatory amendments
• Collaborate with functional leaders to develop optimal development paths and negotiate strategies
• Lead cross-functional teams in preparing briefing packages and health authority meetings
• Ensure regulatory submissions meet highest standards for quality, clarity, and accuracy

Requirements

• Bachelor's degree in life sciences minimum; doctorate preferred (MD, PhD, PharmD)
• 5+ years regulatory affairs experience with doctorate or 8+ years with master's degree
• Experience with biologic products, cell therapy, or ATMP regulatory pathways
• Knowledge of global regulations and health authority expectations (EMA, FDA, Health Canada, MHRA)
• Demonstrated ability to lead cross-functional teams and manage complex submissions
• Strong written and oral communication skills for regulatory documents and submissions

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