Manager CMC Biologics
About the Job
Responsible for the development and execution of regulatory CMC strategy for biologics, including biologics/device combination products.
Represent CMC regulatory on matrix teams while providing strategic guidance related to current regulatory requirements and expectations for BLAs, IND/CTAs, and briefing packages.
Review and provide regulatory assessments on change controls.
Prepare and manage CMC submissions for all global markets while ensuring thoroughness, completeness and timeliness, including creation and maintenance of strategy documents and associated tracking systems.
Manage relationships with diverse teams. Utilize electronic systems for dossier creation and tracking.
Minimum of Bachelor's Degree with minimum of 4 years of related experience.
Knowledge of CMC regulatory requirements for biologics during development and post-approval.
Knowledge of pharmaceutical development, including biologic upstream and downstream processes, analytical methods, and biologic/device combination products.
Demonstrated ability to develop/maintain strong working relationships with the GRS-CMC team and cross functional teams, participate on and/or lead multifunctional teams, handle and prioritize multiple projects and work independently.
Ability to identify, communicate and resolve routine/complex issues. Prepare and manage filings and ensure thoroughness, accuracy and timeliness.
Ability to interpret global regulations and guidance's.
Strong oral and written skills.
Proficient with electronic systems.