Director Regulatory Operations

Outstanding Biotech Company is seeking a Director, Regulatory Operations. As part of this leading Biotech Company's on-going growth, we are currently recruiting for a Director, Regulatory Operations to join the Regulatory team in order to oversee and direct planning, managing, tracking and filing multiple forthcoming submissions, including BLA and MAA filing.

The candidate will be responsible for: will be responsible for: Leading the selection and implementation of the company regulatory operations systems (EDMS, RIMS, Publishing system). Managing the regulatory operations resources (internal and external). Developing and implementing submission management best practices i.e. assisting the Regulatory Leads in preparing regulatory submission packages, gathering necessary source documentation for regulatory filings and documenting them appropriately, keeping track of the planning / progress of regulatory submissions, elaborating retro-planning and alerting for submissions to come. Setting up state-of-the-art document management practices. Hands-on formatting, publishing, performing QCs, and transmitting and archiving the Regulatory Submissions