Regina D Lombardi

Leadership role driving alignment for successful execution of the Quality Systems and Operational strategies and compliance activities within the Sanofi Country organization. Direct responsibility of US Country Quality based Leads, Individual Contributors and Functional Collaborators in Canada. Expanse includes Sanofi BUs (GxP/health-regulated scope). Transversal support of policy, quality global standards, and local requirements, maintaining compliance across US. Risk classification and impact assessments for reporting, escalation & action. Quality Systems and Operations Oversight include(d), but not limited to: Event/Deviation/CAPA, Quality Event/Risk Management, Regulatory Change Management, GxP Computer System Validation/Quality Systems, Samples Compliance Operations, PDMA Reporting, Country Quality Performance Indicators and Analysis, Quality Technical Agreements, Inspection Management, Quality Labeling Review, Quality Documentation and Records Management.

A leadership position within North American Quality, incorporating Good Manufacturing Practices, Field Alerts, Biological Product Deviations, Regulatory CMC, Imports/Registrations, and Labeling. Ensured adherence to company's regulatory compliance, risk management assessment/mitigation and other quality initiatives, providing technical regulatory, CMC and GMP advice. Scope included: Technical regulatory, CMC and GMP counsel concerning submission planning/tracking and supporting data from manufacturing sites with regards to Field Alerts/BPDRs, Labeling, Imports/Exports, and RCMC; Oversight of staff for execution of Field Alert/BPDR submission planning and management; Chairperson of Field Alert Team; Liaison to manufacturing sites and FDA related to Field Alert and Biological Product Deviation activities; Worked effectively with Sanofi manufacturing sites, external manufacturing sites, internal and external business partners and vendors, ensuring clear communication of regulatory requirements; Key decision-making role in risk management and quality events reporting to Global; Accountability for label quality review and approval process, as well as all aspects of the RCMC program for country/local products; Accountability for the preparation of QA/Compliance trend analysis and dashboards for communication of reported and anticipated compliance issues, while effectively allocating QA resources in order to minimize regulatory risk; Strategic technology and process initiatives focus.

Conformance Lead, Conformance Office (CO) Individual contributor, leveraging process expertise and comprehensive understanding of cross-functional roles and system requirements to interpret and evaluate procedures and processes, develop guidance on processes and issues, consults with various groups, and monitors and implements conformance measures that balance business and conformance needs. Leads process, system, and procedure audits, documenting findings and recommending resolutions. Proactively identifies compliance gaps and risks; proposes options to mitigate/remediate; ensures appropriate internal contacts identified and trained for participation; assists in management/closure of findings. Generation of key conformance metrics, identifying deviations, and training needs. Serves as conformance representative and subject matter expert on project teams, ensuring deviation identification and alignment to appropriate procedures/measures.

Team Lead, Global Established Products CMC Managed colleagues & contingents focusing on the EPBU portfolio.Served as the point of accountability for CMC product knowledge, overall product & project-level CMC strategies & ownership of CMC content across the product lifecycle. Showcased a high level of understanding of the technical/regulatory aspects & product characteristics that impact global CMC regulatory strategy of assigned products. Experienced in developing & effectively communicating global regulatory strategies that identify regulatory risks & mitigation strategies & aligns with development and/or commercial plans. Balanced regulatory requirements, constraints & risk posture with partners/customers; leveraged diverse expertise to share and incorporate learnings into CMC strategies & submissions. Partnered with disciplines to develop robust global CMC strategies & regulatory submission plans, delivering market approvals. Evaluated opportunities to reduce submission volume; coordinated/authored CMC content (Modules 1, 2.3, 3, as needed) & query responses that were aligned with CMC strategies. Coordinated authoring/data evaluation/review/approval activities; monitored global CMC submission preparation & execution to ensure global harmonization (reduced customization) while enabling alignment with supply needs. Oversight of the regulatory review process through approval; provided leadership & coordination of regulatory interactions for CMC issues; led CMC meeting preps; attended agency meetings, as required; utilized expertise to influence regulatory negotiations, documenting and communicating CMC outcomes. Proactively managed regulatory commitments, agency queries, annual reports, license renewals to meet regulatory obligations. Effective communication with internal & external teams & impacted stakeholders, providing visibility to upcoming CMC submissions to support submission planning & forecasting to allow efficient utilization of resources.

Associate Research Fellow/Team Lead, Post Approval CMC Managed colleagues and contingent workers focusing on the post approval CMC change management and dossier maintenance for global products, serving as point of accountability for CMC product knowledge, overall product and project-level CMC strategies and ownership of CMC content across the product lifecycle. Key responsibilities include those described for the Director/Team Lead position above.

Senior Manager, Global Manufacturing Compliance Developed regulatory CMC product strategies as a global CMC portfolio lead; led communication and alignment of the portfolio strategies with partners; execution of change management and dossier maintenance activities in support of business initiatives and global regulatory compliance obligations. Ensured global compliance of CMC sections of product dossiers with regulatory commitments via preparation, review, alignment, and update of the NDA and part II sections of the MAA/CTD to current manufacturing practices. Identification and correction of any variances between registration and manufacturing control operations. Preparation of CMC documentation for license renewal and NDA annual reporting. Facilitation of resolution of CMC regulatory queries via the assembling of response data packages. Showcased strong analytical and regulatory writing skills. Effectively organized and prioritized tasks to achieve established targets. Effective collaboration with partners and impacted stakeholders on project teams.

Manager, Global Manufacturing Compliance Developed regulatory CMC product strategies as a global CMC portfolio lead; led communication and alignment of the portfolio strategies with partners; execution of change management and dossier maintenance activities in support of business initiatives and global regulatory compliance obligations. Key responsibilities include those described for the Senior Manager position above.

Pharmaceutical Product Release Supervisor, Pharmaceutical Product Assurance, Quality Operations Performance of duties related to the review and assignment of final status designation to in-process and finished good stages of pharmaceutical product marketed worldwide for multiple pharmaceutical dosage forms; support included, but not limited to the Viagra and Cardura XL global product tablet launches; a member of the plant Quality Operations team, ensuring global compliance of product manufacturing operations/controls with regulatory commitments; investigation of product or process issues, including plant site investigations, as well as laboratory and stability out-of-specification results; completion of annual product record reviews; development of material control documents; participation and completion of Quality Assurance Interdivisional Systems Appraisals; supervisory responsibility for Pharmaceutical Product Assurance Release Clerk. Effective communication and collaboration with plant and center partners, including quality, manufacturing, packaging and laboratory personnel.

Associate, Pharmaceutical Product Assurance, Quality Operations Performance of duties related to the review and assignment of final status designation to in-process and finished good stages of pharmaceutical product marketed worldwide for multiple pharmaceutical dosage forms; completion of annual product record reviews; coordination of the Quality Assurance Investigations program for the site; coordination, handling, tracking, and closure of site product complaints and environmental monitoring reports; development of material control documents; evaluation of all batch test data for processed seals and stoppers, as well as tank, line, and related equipment releases, issuing status designation/approval for use; Quality Assurance Section Safety Meeting Instructor; Procedural Review Meeting Coordinator. Effective communication and collaboration with plant and center partners, including quality, manufacturing, packaging and laboratory personnel.

Technical Project Assistant, In-Process Quality Assurance, Quality Operations Issuance of retrospective and prospective validation task reports, revalidation summarization projects, trend analyses, and computer and manufacturing/packaging equipment qualification and validation protocols; authoring of departmental and standard test procedures, as well as departmental operating instructions.