Jeanne M. Pistillo
Senior Regulatory Affairs Specialist @Abbott
Signup · Get unlimited contacts
WORK HISTORY
Senior Regulatory Affairs Specialist @Abbott
Represent CRM Regulatory Affairs on Rebranding Project Team. Defined the Regulatory Plan by performing numerous Global Regulatory Assessments. • Developed the Rebranding Schedule for US and OUS Product Groups and was final driver for PRA for the product launches by creating GTS licenses. Additionally, approved, and Published eIFU on Website. • Defined the Metrics for the Rebranding Project. Reviewed/Approved for Regulatory, Change Activities and Change Orders directly related to Legal Manufacture name change from St. Jude Medical to Abbott Medical, • Reviewed/Approved device/accessory labels and marketing materials for compliance with Regulations and Rebranding Changes. • Co-Initiated and Co-completed the Manufacturing Site Name changes in EUDAMED and Established the SRN numbers for the associated manufacturing sites. • Authored Notifications and Amendments required by Countries for submission. Filed PMA amendments with FDA for 9 Groups of Medical Devices for Establishment name change. Authored Insubstantial changes and Annual Reportable Changes. Issued COE and CFG for OUS countries. • Reviewer of Product Development Plans and Reports including Design Input/Output, IFU, Manuals, Design Verification and Validation Plans, Labeling, Production Process Qualifications, Installation Qualifications, Operation Qualification, Product performance Qualifications, and Design History files
EDUCATION
University of NE Medical Center, Omaha
PHD objective -Withdrew in good standing
University of Nebraska at Omaha
B.S
University of NE Medical Center, Omaha
M.S
SKILLS
ABOUT JEANNE M. PISTILLO
Global Stability-Biopharmaceutical Professional with over 20 years’ experience in the Pharmaceutical Industry including Research, Drug Development, QMS and Stability. Energetic, hard-working Leader with initiative to get the job done. Planned, organized, and monitored Global Product Stability testing of licensed products for Takeda. Lead of Global Annual Product Quality Review Team for Stability. Certified in Project Management Methodology and Leadership, and a Qualified Instructor. Supervisory Experience. DMAIC, Yellowbelt training (LEAN) and Certified Blue Belt. Excellent problem-solving skills. Experience in Corrective and Preventive Action (CAPA) investigations and Change Control Management. Stability subject matter expert (SME) during audits, inspections. Expert in stability statistical analysis including Discoverant real time trending. Excellent communication and presentation skills. Lead the Stability Commercial Program Integration and authored the Global Stability Process SOP. Biochemist/Molecular Biologist with over 15 years of extensive research and drug development experience in Hematology/Oncology. Diverse set of laboratory techniques and administrative skills. Committed team member and leader of diverse groups supporting and developing drugs. Reputation as go-to person to solve wide variety of experiment related problems.Key Accomplishments• Lead integration with Shire and authored SOP and Standard for Quality Management Systems (QMS). • Lead reduction initiatives for annual stability programs with >1M savings per year.• Project management (PMP certified) included Global Stability Team Lead for Annual Product Quality Reviews.(>200/year) Managed nine Global team members.• Developed and optimized primary hematopoetic cell-based, medium-throughput intracellular FACS staining assay to support kinase inhibitor lead identification and optimization.• Identified key cell cycle check point kinases responsible for underlying molecular mechanisms for synergistic effects of AMG319 with chemo drugs on enhanced proliferation inhibition in lymphoma cells.• Discovered that Neuroglobin (Ngb) mRNA is regulated by HIF-1alpha via its direct binding to the 3’ HRE of Ngb and presented this novel finding at the International Hypoxia Symposium in 2011
This profile is compiled from publicly available professional sources. Unifers is not affiliated with or endorsed by LinkedIn. Request removal of this profile.