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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. 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 gestiAcciones correctivas y preventivasGXPTechnical WritingProject PlanningProject ManagementRegulatory FilingsValidationBioequivalenceAuditorFarmacovigilanciaValidaciTransferencia tecnolTechnology transferRegulatory IntelligenceBatch ReleaseChange ControlCAPATrackwiseCMCGeneric DrugsBuenas pr

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 in 0000 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

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