• Manage, evaluate, and complete regulatory projects consistent with company goals • Plan and manage regulatory activities related to assigned projects that span technical areas including clinical, non-clinical, and CMC • Assist in developing and implementing strategies for the earliest possible approvals/clearance of regulatory submissions associated with assigned projects • Manage the preparation, including writing as necessary, assembly, review, and timely submission of regulatory dossiers as required for investigation and registration of products in the US and abroad • Ensure regulatory submissions are maintained in compliance with regulatory requirements. Support and manage preparation of meeting requests and briefing documents • Manage the preparation, review, and submission of all components of regulatory submissions including INDs and amendments, BLAs/NDAs and supplements, annual reports, safety reports, etc • Participate on project teams and provide expertise on regulatory matters • Develop and maintain current regulatory knowledge and advise management of significant developments. Ensure compliance with departmental requirements including maintenance of regulatory archive. • Work with external regulatory consultants/CROs as required