Associate Director, CMC Regulatory Affairs, International
This role involves leading CMC regulatory strategies and submissions for international markets, with a focus on mRNA-based products across vaccines, oncology, and rare diseases. The individual will guide global regulatory compliance, interact with health authorities, and support manufacturing and quality teams through regulatory interpretation and change control. It requires deep expertise in CTD-format filings and a proactive approach to managing multi-therapeutic regulatory programs in a fast-paced environment.