Executive Director, Regulatory Affairs – Clinical European/Global Focus

Das ist der Job

Our path to success is clear and well‑defined, and Vaxcyte is set up to go the distance.

Darum lohnt es sich

Executive Director, Regulatory Affairs (Contract) – Clinical European/Global Focus Join our Mission to Protect Humankind! Vaxcyte is a clinical‑stage vaccine innovation company engineering high‑fidelity vaccines to protect humankind from the consequences of bacterial diseases, which have serious and costly health consequences when left unchecked.

Working to eradicate or treat bacterial infections such as invasive pneumococcal disease, Group A Strep, and Shigella is just the beginning.

Summary This leadership role is responsible for developing and implementing global regulatory strategies for clinical investigational studies and commercialization of vaccines for both adult and pediatric populations.

In collaboration with Clinical Development and Safety, this role provides regulatory guidance that enables and facilitates the preparation of clinical development protocols, interpretation and summary of clinical results, initiation, development and preparation of clinical and pre‑clinical regulatory documents, correspondence and responses to regulatory authorities toward commercial regulatory approval of novel vaccine products.

Essential Functions Develop and execute globally viable clinical regulatory strategies. Develop, author and review regulatory CMC documentation for submission including application documents, correspondence and responses to queries. This includes requests for scientific