Regulatory Affairs Sr. Manager
Key Accomplishments:• Develop and Standardize CMC authoring, publishing and document management processes across various Corporate Sites and Divisions.• Interface with Technical Quality groups (QA, QC, Process Development, and Technical Operations) for submission timelines and authoring of documentation.• Support Regulatory Affairs Strategist in the preparation of Regulatory Filings.• Coordinate and lead high performing, cross-functional teams to progress business milestones.• Ensure appropriate staffing resources, processes and systems are in place to submit Regulatory dossiers, in order to meet department and corporate objectives and goals.• Harmonize the migration of doc-base systems (standardized folders structure); Implement global authoring templates; Ensure correct eCTD content is provided in submission templates and reviewed for completeness and compliance to eCTD standards.• Facilitate eCTD life-cycle and granularity decisions of all Regulatory CMC dossiers and Health Authority responses.• Publish and Submit eCTD Submissions• Train Regulatory Affairs and Author Community on MS Word Authoring Styles and Document Management • Author Best Practices procedures, Training Guides, SOPs and Performance Qualification (PQ) and Operational Qualification (OQ) scripts for system configurations and upgrades.• Maintain and Design customized folder structure in Documentum (First Doc System); Ensure submitted information is accurately documented in cGMP systems; Manage and archive all Regulatory documentation submitted to Health Authorization. • Lead and participate in testing and validation of new software tools and configurations.
