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Summary

i am an enthusiastic and eager-to-learn professional with experience in Life Sciences in both the academic and the biotech industry environments. i have a phd in Biomedical Sciences and over 9 years experience at Research laboratories, working with Molecular and Cellular Biology, as well as with applied sciences. furthermore, i have acquired knowledge at an international level in the biotech Regulatory Affairs environment, contributing actively to the new registration and maintenance of vaccine licenses for worldwide destinations. i have strong Communication and Problem-solving skills, as well as excellent writing and presentation capabilities. moreover, i developed skills in the Planning, execution and critical Analysis of scientific data. my combined scientific and Regulatory Affairs background assures delivery of the right level of information to concerned Health authorities, rendering Compliance to regulatory requirements and assuring business continuity. i am a team-player, with demonstrated Leadership skills by driving performance, managing multidisciplinary projects and contributing to people development and Training.

Experiences

Current Experience

  • Regulatory Affairs CMC Specialist


    Since September 2016
    responsible for transversal product-related writing activities, including the writing and edition of technical regulatory documents to support development and registration of new Vaccines, as well as to ensure maintenance of existing vaccine licenses (life-cycle). further responsibilities include stakeholder management, providing input in strategic and scientific expertise to advisory bodies, and the participation in adequate and efficient interactions with regulatory authorities to optimize scientific ra Strategy and content of regulatory documents and files. additional responsibilities: -ensure adequate liaison with data generating units to receive documents/information/data suitable for preparation of high-quality files in a timely manner; -subject matter Expert for secondary Operations and document standardization, supporting business improvement and assuring sustained support within and outside the Regulatory Affairs department; -people management: mentoring and Coaching across different teams in the department; -business improvement initiatives; -Project Management support. Responsible for transversal product-related writing activities, including the writing and edition of technical regulatory documents to support development and registration of new vaccines, as well as to ensure maintenance of existing vaccine licenses (life-cycle). Further responsibilities include stakeholder management, providing input in strategic and scientific expertise to Advisory Bodies, and the participation in adequate and efficient interactions with regulatory authorities to optimize scientific RA strategy and content of regulatory documents and files. Additional responsibilities: -Ensure adequate liaison with data generating units to receive documents/information/data suitable for preparation of high-quality files in a timely manner; -Subject Matter Expert for Secondary Operations and Document standardization, supporting business improvement and assuring sustained support within and outside the Regulatory Affairs department; -People management: Mentoring and coaching across different teams in the department; -Business improvement initiatives; -Project management support.

Past Experience

  • Regulatory Affairs Expert Consultant

    July 2015 --- September 2016
    responsibilities include: -writing cmc parts of regulatory variations for eu, us and international countries -writing module 2 of regulatory files derived from completed eCTD modules 3 -response to questions raised by regulatory authorities on cmc matters -involvement in internal initiatives for improvement of processes/ways of working

  • Wetenschappelijk medewerker

    October 2010 --- June 2015
    Researcher on the Immunology and molecular biology field involving dendritic cells. responsible for managing and executing projects, as well as introducing new molecular biology techniques in the Lab, on the investigation of the molecular signature of the immunomodulatory effects of vitamin d in human dendritic cells. exploring the Translation of tolerogenic dendritic cells into Clinical Applications. further responsibilities: -Training and project supervision of master/phd students and personnel; -writing national and international grant proposals; -reporting and presenting results both written and orally; -establishing national and international collaborative work; -Lecturer for master/phd students in Biomedical Sciences; -organization of scientific and laymen events.

  • PhD student

    September 2006 --- September 2010
    the major topic of my phd dissertation was to investigate the immunomodulatory effects of calcitriol and its analogues on the maturation and differentiation process in human dendritic cells (dcs). in the frame of my phd dissertation i proposed to use different approaches in order to understand the molecular mechanisms involved in these processes in dcs - 2d-dige and tandem Mass Spectrometry, Protein interactome Analysis and extensive functional Testing of dcs In Vitro.

  • Undergraduate researcher

    August 2004 --- February 2006
    the main purpose of my undergraduate thesis project was to use Proteomics techniques and analyze the mitogenic effect of human recombinant prolactin (rhprl) in primary cultures of human pancreatic islets.

  • Intern

    August 2003 --- July 2004
    topic: proteomic Analysis of the anti-tumor effect of glucocorticoids and all-trans retinoic acid in rat glioma cells.

  • Intern

    March 2002 --- December 2002
    topic: evaluation of antibiotics resistance of an epidemic staphylococcus aureus strain in brazilian Hospitals

Personality

Self Assessment :
AdaptabilityProblem solvingProactivityOrganizationOptimismInterest in knowledgeKindnessEfficiencyCuriosityCritical thinkingCoordinationCollaborationAttention to detailAssertivenessAnalytical thinkingSelf-confidence

Knowledge

LinkedIn Assessment :
molecular biologyCell CultureImmunologyCell biologyProteomicsLife SciencesProtein chemistryBiochemistryScientific WritingProject ManagementLifesciencesCommunication SkillsWritten & Oral Presentation SkillsRegulatory affairsVaccinesMentoring

Skills and Expertise

Self Assessment :
Design protocolDesign scientific projects (in biology)Ensure data consistencyEnsure good clinical practice (GCP)Evaluate protocolsInterpret dataLiaise with research teamlifescienceManage laboratory proceduresManuscript reviewManuscript preparation and reviewManuscript preparationNegotiate protocol details NetworkOral presentationOrganise meetingsPrepare final reportPublication of articlesProvide trainingPublish scientific projectsRead medical literatureReport dataResolves queriesResearch at universitiesStatistical analysisSolve problemsSupervise techniciansSupervise data processingWrite papersWrite protocolsWritten presentation Analyze data Create SOPs Develop protocols Guide students Interact with physicians Interpret data Report data Technology research Write papersAdjust methodsAnalyze dataAnalyze proteinAttend investigator meetingAttend seminarsCoach staffCommunicate with investigatorConduct research at universitiesConduct university research Control datacoordinating research projectsCreate standard operating procedure (SOP)Data analysisData miningData verification

Education

  • Doctor of Philosophy (PhD) in Biomedical Sciences, General from KU Leuven in 2010
  • Bachelor's degree in Biological Sciences from University of São Paulo in 2006
  • Master's degree in Medical Sciences from KU Leuven in 0000

Training and Certification

  • Introduction to Project Management in 0000 Certification
  • Laboratory Animal Sciences in 0000 Certification

Languages

BrightOwl Assessment:
Self Assessment:
Portuguese
Native
English
Full Proficiency
Dutch
Full Proficiency
French
Professional Proficiency
German
Elementary Proficiency

Work Preferences

  • Work From Home:
    No
  • International:
    Yes

Area / Region

Leuven, Belgium

Others

Driving License
  • Yes

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