Regulatory Manager, Regulatory Affairs - CMC (Gene Therapy)
Do you want to be part of an inclusive team that works to develop innovative therapies for patients? Every day, we are driven to develop and deliver innovative and effective new medicines to patients and physicians. If you want to be part of this exciting work, you belong at Astellas!
Astellas Pharma Inc. is a pharmaceutical company conducting business in more than 70 countries around the world. We are committed to turning innovative science into medical solutions that bring value and hope to patients and their families. Keeping our focus on addressing unmet medical needs and conducting our business with ethics and integrity enables us to improve the health of people throughout the world. For more information on Astellas, please visit our website at www.astellas.com.
This position is based in Northbrook, Illinois. Remote work from certain states may be permitted in accordance with Astellas’ Responsible Flexibility Guidelines. Candidates interested in remote work are encouraged to apply.
Purpose and Scope:
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.
Essential Job Responsibilities:
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 against regulatory requirements and reviews submissions against 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 Astellas 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.