The Manager of Regulatory Affairs Pompe will report to the Director, Regulatory Affairs and is accountable for the preparation, coordination and management of regulatory submissions supporting the POMPE program. The incumbent will work within a group setting to act coordinate assigned Regulatory Affairs activities with other functional areas including external CROs, partners, and consultants in the planning, organizing, and preparing of regulatory documents as required for submission to governmental regulatory agencies. This individual will have a solid understanding of FDA regulations and ICH guidance’s and experience with regulatory submissions, including INDs, international clinical trial applications, and marketing applications in Common Technical Document format. The ideal candidate will have excellent written and effective verbal communication skills, proficient in project management, is flexible, and able to work in a fast paced environment.
Roles and Responsibilities
- Actively contribute to the operational implementation of regulatory strategy for assigned projects
- Prepare, coordinate, manage or maintain regulatory submissions (e.g., INDs, CTAs, amendments, safety reports, DSUR, annual reports, meeting packages, etc.) in accordance with applicable regulations. This includes ability to coordinate identified regulatory requirements into reliable submission plans; develop & maintain timelines; coordinate internal/external authoring/review/comment adjudication and finalization (submission and archival).
- Provide review and comment during document preparation, including consideration of regulatory/ICH guidance/requirements pertaining to document strategic purpose and content
- Interface with external regulatory groups (e.g., CRO, partner, consultants, etc.) in the preparation/review/compilation/finalization/submission/posting of regulatory submissions
- Coordinate Regulatory Affairs activities with other functional areas as required including representation Regulatory Affairs in cross-functional team meetings
- Provide regulatory support for clinical operations activities (e.g., review of essential documents, and development and review of consent forms, etc.)
- Initiate and/or contribute to local process improvements which have an impact on Regulatory Affairs, including the authoring and review of standard operating procedures (SOPs)
- Remain current on regulatory requirements (e.g., Domestic and International) supporting the regulatory strategy and clinical operations related activities.)