The Director of Regulatory CMC will lead regulatory strategy and execution for drug development programs to ensure compliance and speed to market. This role involves overseeing CMC documentation, interacting with health authorities, and collaborating with cross-functional teams to advance rare disease therapies.
The Director of Analytical Development manages the development and tracking of testing methodologies for drug substances and products while coordinating with internal teams and external CROs/CMOs. They are responsible for ensuring analytical activities align with project objectives, supporting regulatory filings, and overseeing stability tracking and method validation.
The Commercialization Project Manager drives product commercialization activities within the supply chain, acting as the primary link between packaging and regulatory departments. They are responsible for managing change controls, supporting product variation management, and ensuring the synchronization of regulatory and artwork timelines.
Lead statistical genetics analyses of population-scale genomics data to inform business opportunities and internal development programs. Collaborate with cross-functional teams to translate analytical findings into actionable insights for target identification and clinical development.
The Senior Manager will oversee SAP FICO, Group Reporting, and BTP support activities, ensuring timely resolution of issues and maintaining system compliance. This role also involves managing the integration between SAP and Coupa, driving continuous improvement within finance applications.
