About the job
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Position Summary:
The Executive Director of Clinical Regulatory is a leadership role responsible for crafting and executing global regulatory strategies for clinical investigations and the commercialization of vaccines across both adult and pediatric populations. Working closely with Clinical Development and Safety teams, this position will provide regulatory oversight that supports the preparation of clinical development protocols, interpretation and summarization of clinical data, and the creation and management of clinical and pre-clinical regulatory documents. This role also entails liaising with regulatory authorities to secure commercial approval for innovative vaccine products.
Candidates should possess extensive experience in developing and executing regulatory strategies for vaccines and preparing investigational and commercial regulatory submissions, such as IND/IMPD, BLA/MAA, and post-approval clinical and safety notifications. Strong communication skills are essential, particularly the ability to simplify complex regulatory issues and effectively convey potential options and opportunities.

