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Summary

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.

Experiences

Current Experience

  • 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.

Past Experience

  • 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.

  • Analitical Development
    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).

Personality

Self Assessment :
Attention to detailAdaptabilityCollaborationCoordinationDiligenceOptimismProactivityAnalytical thinkingProblem solving

Knowledge

Self Assessment :
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
LinkedIn Assessment :
Regulatory affairsCMC Regulatory AffairsQuality Assurance (QA)Asuntos normativosEmerging MarketsGlobal Regulatory ComplianceLabellingPharmaceutical DevelopmentICH guidelinesHealth & Safety LegislationPharmacovigilanceQuality SystemsQuality AuditingDocumentumSistema de gestión de la calidadAcciones correctivas y preventivasGXPTechnical WritingProject PlanningProject ManagementRegulatory FilingsValidationBioequivalenceAuditoría del control de calidadFarmacovigilanciaValidaciónTransferencia tecnológicaTechnology transferRegulatory IntelligenceBatch ReleaseChange ControlCAPATrackwiseCMCGeneric DrugsBuenas prácticas (GxP)

Skills and Expertise

Self Assessment :
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

Education

  • 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

Languages

BrightOwl Assessment:
Self Assessment:
Spanish
Native
English
Professional Proficiency
Italian
Professional Proficiency
Dutch
Elementary Proficiency

Work Preferences

  • Positions I am interested in:
    Regulatory Affairs Consultant Regulatory Affairs Manager Senior Regulatory Affairs Specialist
  • Locations I am interested in:
    Netherlands
  • Work From Home:
    No
  • Work Regime:
    Permanent position :    80-100% FTE
    BrightOwl freelancer :    32-40 Hours per week
    BrightOwl employee :    80-100% FTE
  • International:
    Yes

Area / Region

Breda, Nederland

Others

Driving License
  • No