Associate Director, CMC Regulatory Affairs, International
This role involves leading CMC regulatory strategies for international submissions, including IND/CTA/BLA/MAA filings, with a focus on mRNA-based medicines. The individual will guide global regulatory compliance, interact with health authorities, and support quality and manufacturing teams across therapeutic areas like vaccines, oncology, and rare diseases. It requires deep expertise in biologics CMC regulations and a proactive approach to navigating complex regulatory landscapes.