Regulatory Affairs Professional with more than 6 years of experience in the Pharmaceutical Industry. A former Pharmacist with relevant scientific and therapeutic knowledge on medicinal products, ensuring timely filings of appropriate documents and used to work in GxP environments. A goal-driven, pro-active and client-oriented team player, enjoying at communicating with diverse audiences. Above all, I consider myself a positive thinker. Expertise: New Products Introduction, Portfolio Maintenance (pre & post-approval changes), Licensing in/out (EU/US/Emerging Markets), CMC, Labelling, PhVig, Project Management, Tech Transfers & Lean Six Sigma. Currently interested in new challenges within Biopharmaceutical and/or Medical Device Industry.
Product Release Officer
Since April 2015
Coordinate and Support Global Distribution Site and align with relevant teams (Regulatory, Trade, IT) on cross-border shipments control (regulatory and import license) SAP GTS implementation.
Senior CMC RA Manager
July 2014 --- March 2015
Support CEO on starting-up activities (internal/external audits, QMS implementation).
Global Regulatory Affairs – Network CMC Specialist
May 2013 --- March 2015
By Starodub B.V. (Jul14 - Mar15) By Zwiers consultancy (May13 – Jul14) > Coordinate and Support Global tech transfers (CMC changes). > Align with PM and relevant teams (Ops, Supply) on RA strategy. > Provide input on planning, drive for execution and follow-up with Local Sites until HA approval. > Keep internal databases up-to-date. > Support (CMC) change controls. > Support compliance projects.
Regulatory Affairs Expert
January 2012 --- April 2013
> Support in-house developments (NPIs). > Coordinate data collection and dossier writing / submission (full registration dossier). > Support customers on new/changes on APIs (provide variation packages or relevant data for keeping their dossiers up-to-date) distributed by GLN on behalf of Dr. Reddys (local Representative in Spain & Portugal. > Support license-in/out of registration dossiers from/to 3rd parties. Coordinate transfer of ownership and related activities. > Support portfolio maintenance (variations, renewals, PSURs...). > Support MOW applications (tenders, CPPs..). > Keep internal databases up-to-date. > Coordinate new PhVig system implementation.
Local RA Officer
April 2010 --- January 2012
> Support in-house developments (NPIs). > Coordinate data collection and dossier writing / submission (full registration dossier). > Support license-in of registration dossiers from 3rd parties. Coordinate transfer of ownership and related activities. > Support portfolio maintenance (variations, renewals, PSURs...). > Keep internal databases up-to-date. > Support Global teams on trackwise implementation in the Spanish affiliate. > Support Global teams on documentum implementation in the Spanish affiliate. > Coordinate due diligences on registration dossiers coming from 3rd parties.
Local QA Technician
October 2009 --- March 2010
> Support batch release and QA related activities (complaints, deviations, change Controls, CAPAs). > Support re-branding and labelling changes (Merck Generics to Mylan). > Keep internal databases up-to-date. > Support Quality System (SOPs). > Coordinate GMP training.
November 2008 --- October 2009
> Collect relevant data for stability, bioequivalence, cleaning process/validation, manufacturing process/validation protocols/reports. > Keep analytical methods, specifications, COAs up-to-date with USP/Eur Ph. updates. > Coordinate calibrations and qualifications (IQ, OQ, PQ) of lab equipment’s. > Coordinate selection, approval, certification of different suppliers (API, excipients and raw materials).
Attention to detailAdaptabilityCollaborationCoordinationDiligenceOptimismProactivityAnalytical thinkingProblem solving
Regulatory affairsRegulatory StrategiesRegulatory submissionsRegulatory RequirementsUnderstanding of regulatory guidelinesCMCLabellingICHGXP Scientific writingData ManagementMarketing approvalMarketing Authorisation Application (MAA)Project ManagementScientific WritingSOPWriting Study Procedures and SOPsMarket accessMarket accessRisk Management PlanPharmacovigilanceDrug Safety and PharmacovigilancepharmaPharmaceutical IndustryR&DDrug development process
Skills and Expertise
Analyze data Create SOPs Report dataAdjust processes and methodsChemistry Manufacturing and Controls (CMC) activitiesCompile registration dossiersSubmit registration dossiersApprove RMPsFollow-up RMPsSubmit Clinical Trial DossiersReview educational materialsSubmit Periodic Safety Update Reports (PSURs)Submit Analyte Specific Reagents (ASRs)Submit clinical study reports (CSRs) Assure medical qualityFollow-up of quality assurance activitiesFollow-up of Quality Management System (QMS) processesMaintain Quality Management System (QMS)Manage Quality Management System (QMS) documentationReview quality policiesSet-up quality policies Assure medical qualityImplement Quality Management System (QMS)Develop regulatory strategyGenerate regulatory submissions Late-stage regulatory filing (MAA, BLA)Prepare regulatory documentsWriting regulatory documents
Master in Pharmaceutical and Parapharmaceutical Industry in Pharmaceutics and Drug Design from CESIF in 2009
University Degree in Pharmacy from University of Granada in 2008
Erasmus Program in Pharmacy from University of Messina in 2007
Training and Certification
Yellow Belt, Lean Sig Sigma - Problem Solving and Process Improvement Certification