About the job
Join Our Mission to Safeguard Humanity!
Position Overview:
The Executive Director of Regulatory Affairs will spearhead the development and execution of global regulatory strategies for clinical investigative studies and the commercialization of vaccines targeting both adult and pediatric populations. This leadership role involves close collaboration with Clinical Development and Safety teams to provide regulatory guidance that streamlines the preparation of clinical development protocols, interpretation and summarization of clinical results, and the initiation and preparation of clinical and pre-clinical regulatory documents. Additionally, this role will involve correspondence and responses to regulatory authorities, facilitating commercial regulatory approval of novel vaccine products.
To excel in this position, candidates must possess substantial experience in formulating and executing regulatory strategies for vaccines, as well as in preparing investigational and commercial regulatory applications, including IND/IMPD, BLA/MAA, and post-approval clinical and safety notifications, alongside securing global regulatory approvals. Exceptional communication skills are essential, particularly the ability to distill complex issues and regulatory risks while effectively articulating options and opportunities.