Associate Director, Global Regulatory Affairs

The Associate Director, Global Regulatory Affairs leads regulatory activities for early and late-phase investigational products, overseeing the preparation and submission of INDs, CTAs, and marketing applications. This role involves providing strategic regulatory guidance, monitoring global regulatory developments, and collaborating with cross-functional teams to ensure compliance with agency expectations. The position requires managing regulatory intelligence, responding to authority inquiries, and contributing to the implementation of internal processes and SOPs.