Associate Director, Regulatory Affairs

Iovance Biotherapeutics · Remote

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Role summary

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.

What they're looking for

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

What you'll be doing

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

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