Self Directed Domestic Goddess

• Nov 2020 - Present

CP Regulatory and Stewardship Ops

• Apr 2019 - Nov 2020

Senior Regulatory/Stewardship Specialist

• Sep 2008 - Apr 2019

Senior Regulatory Affairs Specialist

• Feb 2007 - Sep 2008

• Post-Approval maintenance for all Merz US prescription drugs, including annual reports, periodic ADE reports, supplements, including change control review • Provide global regulatory guidance for 6 development projects; compile IDE, IND, NDA and PMA submissions, adverse event reporting; technical writing, label writing and data searches • Communicate with FDA on a regular basis regarding pre and post marketed products and medical devices (class III)• Submit eCTD’s through the FDA… • Post-Approval maintenance for all Merz US prescription drugs, including annual reports, periodic ADE reports, supplements, including change control review • Provide global regulatory guidance for 6 development projects; compile IDE, IND, NDA and PMA submissions, adverse event reporting; technical writing, label writing and data searches • Communicate with FDA on a regular basis regarding pre and post marketed products and medical devices (class III)• Submit eCTD’s through the FDA Gateway• Responsible for DDMAC submissions, Ad/Promo review• Project manager for the Quality System assessment, assist in transformation of SOP's into new global format at Merz US• Facilitate Regulatory and R&D SOP maintenance; create new SOP's and working instructions Show more Show less

Medical Transcriptionist

• Jul 2000 - Feb 2007

Provided medical transcription services for 3-4 internists at Eagle Family Medicine at Brassfield. I was self employed and worked remotely during this time.

Contract Study Monitor

• Jul 2000 - Feb 2007

Oversaw the progress of clinical animal health studies for Novartis Animal Health, ensuring that they were conducted, recorded, and reported in accordance with the protocol, SOPs, GCPs and applicable regulatory requirements.

Quality Assurance Associate

• Feb 2000 - Jul 2000

• Audit NCIE’s for FDA Submission• Oversee Production of FDA regulated product, assuring GMP compliance of production• Assist in development and finalization of SOPs• Audit protocols, protocol amendments, summary reports, raw data and other associated regulated documents to assure FDA compliance • Schedule and conduct facility inspections

Regulatory Compliance Auditor

• Apr 1997 - Jul 2000

• Monitor compliance of domestic and foreign processes and products, both pre-and post-approval • Schedule and conduct contract facility audits and internal systems audits• Conduct reviews of protocols, protocol amendments, summary reports, final reports, and data packets• Continuous review, implementation and update of all Novartis Animal Health, Inc., Standard Operating Procedures to ensure compliance with GMP’s, GLP’s and GCP’s• Prepare NCIE’s for submission to FDA… • Monitor compliance of domestic and foreign processes and products, both pre-and post-approval • Schedule and conduct contract facility audits and internal systems audits• Conduct reviews of protocols, protocol amendments, summary reports, final reports, and data packets• Continuous review, implementation and update of all Novartis Animal Health, Inc., Standard Operating Procedures to ensure compliance with GMP’s, GLP’s and GCP’s• Prepare NCIE’s for submission to FDA • Maintain all product stability data for FDA submissions • Prepare all ADE reports for review and submit approved ADE’s to FDA• Prepare and submit all state registration/listing documents• Prepare all Material Safety Data Sheets (MSDS) • Assist in the preparation of regulatory submissions to FDA and EPA Show more Show less

Chemical Technologist

• Sep 1988 - Feb 1994

• Analysis of water and soil samples, as well as, data analysis for various pesticides and their metabolites, using GC-MSD, LC-MS and GC-NPD• Drafting and finalizing residue test reports and compiling appropriate data for auditing and archival of said data after supervisor’s approval• Development, modification and finalization of residue methods• Perform balance work and sample preparation for various samples• Perform extractions, separations and basic analytical… • Analysis of water and soil samples, as well as, data analysis for various pesticides and their metabolites, using GC-MSD, LC-MS and GC-NPD• Drafting and finalizing residue test reports and compiling appropriate data for auditing and archival of said data after supervisor’s approval• Development, modification and finalization of residue methods• Perform balance work and sample preparation for various samples• Perform extractions, separations and basic analytical procedures• Assist in training colleagues in various water laboratory procedures, GLP’s and the operations and principles of basic equipment Show more Show less