Regulatory Affairs Planning Resource I

Backfill: ASTLJP00002527
**CANDIDATE MUST START WORK AT 7AM EST**
Responsible for developing regulatory CMC strategy for assigned projects. Identifies and collects CMC data required for regulatory submission packages. Plans and prepares CMC regulatory packages, assesses changes for potential regulatory impact, responds to action letters, and maintains filings and approvals. Utilizes working knowledge of CMC to effectively interpret CMC development and changes and determine the impact on the project or product and the application. Acts as CMC regulatory lead or deputy for complex projects/products, requiring advice from manager on complex issues Manages technical documents for preparation, review and submission to regulatory agencies. Prepares INDs/CTAs & NDAs/MAAs, amendments & supplements, as well as responses to questions from regulatory agencies. Assesses scientific data aProductst regulatory requirements and reviews submissions aProductst regulatory strategy. Ensures proper CMC Dossier Management, including document version control. Ensures compilation and transmittal of submissions are within defined schedules and meet Health Authority and Client established standards/SOPs. Develops approach for new assignments having less-defined regulatory frameworks with management oversight. For assigned projects, monitors and facilitates resolution of CMC issues that have potential for regulatory impact. Regularly interacts with functional peer groups internally and externally, occasionally with senior management. Advises local teams on regulatory requirements. Interprets and ensures compliance with applicable Health Authority/ICH regulations. Stays informed of changes in Health Authority regulations and expectations, and shares lessons with others.