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Lori Steiner's Jobs at NeedLS
Principal and Owner | NeedLS

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Lori Steiner's Top 3 Jobs

Science & Biotech - Durh, NC 27710

this individual will have responsibility for providing CMC regulatory leadership and strategy required to achieve regulatory approvals, collaborating closely with multiple scientific, technical, quality, and commercial areas within the company and with external contract manufacturing organizations (CMOs). This position provides knowledge, understanding, interpretation, and utilization of regulatory guidances and regulations, as well as industry and government agency best practices and trends. Responsibilities: Lead, develop, and implement CMC r...

View Sr. Director CMC Regulatory Job - Durh, NC 27710
Science & Biotech - Durham, NC 27710

The Manager Drug Regulatory Affairs is responsible for planning, managing and tracking regulatory documentation, and successful preparation and filing of submissions (DMF, ANDA, NDA) in the required electronic format. This role serves as the system owner for regulatory information tools and technologies, and develops processes to ensure submission are complete and comply with applicable regulatory requirements, in a fast-paced environment. This individual collaborates with cross-functional teams (RA, QA, IT, etc.) to bring excellence in regulatory p...

View CMC Regulatory Manager Job - Durham, NC 27710
Science & Biotech - Cambridge, MA 02138

A highly visible position repsponsible for creating and executing program stategy for research organization to lead programs to IND and clinical development. Responsibilities: • Responsible for creation, management, and communication of Integrated Development Plan • Lead cross-functional communication, drive strategic and operational alignment with the program team, functional leads, and Executive Leadership Team • Work with a cross functional team to prepare study designs, manage budgets and oversee the study from initiation to report generation...

View Sr. Director, Program Management Job - Cambridge, MA 02138