Jackie S.

About Jackie S.

Senior Regulatory Affairs professional with 20+ years of experience spanning submissions support, post-approval lifecycle management, and regulatory compliance across small molecules, biologics, and combination products.Currently focused on regulatory documentation, submission readiness, and lifecycle management, partnering closely with Manufacturing, Quality, and Technical Operations to ensure regulatory expectations are met. Works with cross-functional teams to interpret complex technical data, clarify what is changing, and translate that into actionable regulatory guidance.Over the last few years, has led initiatives to improve regulatory data accuracy, streamline submission readiness, and support teams in evaluating supplier and product changes. Finds the most engagement and delivers the most value in analytical and problem-solving work that directly informs regulatory decisions.Core strengths include:• Submission readiness and regulatory documentation• Regulatory impact assessment and lifecycle management• RA systems (Veeva RIM) and cross-functional regulatory analysis• FDA, EMA, and ICH-compliant execution

Experience

1. Senior Manager Regulatory Affairs

   Emergent BioSolutions

   Jan 2025 — Present · Dayton, OH, US

   Serve as global Regulatory Affairs owner for post-approval change impact assessment, evaluating CMC changes for regulatory risk, filing requirements, and lifecycle strategy across multiple product types and regions.• Own and govern the RA Change Control process, defining assessment criteria, decision pathways, and documentation standards to ensure consistent, inspection-ready outcomes.• Led the standardization of change-related metadata within Veeva RIM, improving global visibility, regulatory traceability, and reporting accuracy for post-approval submissions.• Implemented a global process for annual CARES Act drug volume reporting, ensuring regulatory compliance and cross-site alignment.• Partner with Manufacturing, Quality, Technical Operations, and external vendors to translate CMC changes into regulatory strategy, supporting post-approval submissions and health authority responses.• Coordinated and contributed to the authoring of a Type C FDA meeting request and briefing package, ensuring clear articulation of CMC regulatory considerations and agency engagement readiness.

Education

• Wright State University

  Bachelor of Science, Chemistry

Skills

• R&D
• Trackwise
• Quality Assurance
• Research and Development (R&D)
• Analytical Chemistry
• Ep
• Quality Control
• Gmp
• Ectd
• Deviations
• Cmc
• Ctd
• Batch Release
• Supplier Evaluation
• Change Control
• Raw Materials
• Documentum
• U.s. Food and Drug Administration (Fda)
• Complaint Investigations
• Pharmaceutical Industry
• Sop
• Fda
• 21 Cfr Part 11
• Standard Operating Procedure (Sop)
• Ncmr
• Cgmp Practices
• Dissolution
• Regulatory Affairs
• Validation
• Regulatory Filings
• Medical Devices
• Capa
• Regulatory Submissions
• Gxp
• Quality Auditing
• Quality System
• Pharmaceuticals
• Drug Development
• Corrective and Preventive Action (Capa)
• Anda