Shanna Hurts

Alumni Advisory Council member at Vlaams Farmaceutisch Studenten Overleg (VFSO)
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Contact Information
us****@****om
(386) 825-5501
Location
BE
Languages
  • Dutch Native or bilingual proficiency
  • French Limited working proficiency
  • English Professional working proficiency

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Credentials

  • GMP: ICH Q7, FDA Qa7 for API, Eudralex (V4, Part II API), FDA Guidance Data Integrity
    Q-Academy
    Oct, 2017
    - Oct, 2024
  • 10th EPSA Autumn Assembly, Valencia, Spain
    European Pharmaceutical Students' Association
  • 11th EPSA Autumn Assembly, Hradec Kralove, Czech Republic
    European Pharmaceutical Students' Association
  • 16th EPSA Summer University, Ohrid, Macedonia
    European Pharmaceutical Students' Association
  • 37th EPSA Annual Congress, Budapest, Hungary
    European Pharmaceutical Students' Association
  • 38th EPSA Annual Congress, Toulouse, France
    European Pharmaceutical Students' Association
  • Quintiles University Summer School 2015
    Quintiles

Experience

    • Belgium
    • Pharmaceutical Manufacturing
    • 1 - 100 Employee
    • Alumni Advisory Council member
      • Sep 2014 - Present

      - Founder: together with 7 other pharmaceutical students, I wrote the statutes of the association. I also drafted the bylaws which were adopted by the General Assembly.- Giving advice and support to the VFSO team members, making sure that the vision and mission of the association is respected. Supervising and coaching the team members and their projects/activities during the mandate.

    • Working group Farma Career Day
      • Apr 2016 - Apr 2016

      - Organisation of the first Farma Career Day, a job fair attended by 400 pharmaceutical students and young graduates.- Designed and shaped several posters to explain job opportunities for my fellow students. I gathered information and testimonials from young professionals in my network to obtain a realistic visualisation of their specific job responsibilities and tasks. - Primary contact person for several workshop lecturers and exhibitors.

    • Ireland
    • Pharmaceutical Manufacturing
    • 700 & Above Employee
    • Senior Regulatory Affairs Specialist
      • Oct 2022 - Present

    • Senior Regulatory Affairs Associate
      • Apr 2020 - Oct 2022

    • United States
    • Research Services
    • 700 & Above Employee
    • Regulatory Affairs Associate I
      • Nov 2017 - Apr 2020

      - Act as a Local Regulatory Affairs Lead (LRAL) for Belgium and the Netherlands. - Prepare, submit and follow up on initial and amended RA, IEC and any other central submissions required in Belgium and the Netherlands, within contracted timelines and budget, including the creation and modification of documentation required for approval. - Provide information relating to local importation and exportation and for carrying out all practical steps to ensure that importation and exportation requirements are met for the IP and any other clinical trial supplies needed for the trial. - Provide review of the translation into the local language of clinical trial supply labeling to ensure it meets local regulatory requirements. - Ensure that Insurance Certificates, Country Specific ICF and any other patient documentation adheres to country requirements. Show less

    • Belgium
    • Pharmaceutical Manufacturing
    • 1 - 100 Employee
    • Junior Regulatory Affairs Officer
      • Feb 2017 - May 2017

      - European (mainly BeNeLux countries) regulatory affairs for medicinal products and healthcare products. - Life cycle management for registered medicinal products and notified health care products. - Creation, adaptation, verification of SmPC's, PIL's, labeling and QA supervision of packaging materials. - Supervision of promotional activities. - Keep up-to-date with the latest developments in science and relevant legislation. - Creation and maintenance of QMS and SOP writing. - Follow-up of inspections/audits and CAPA. - Preparation of BMR templates. Show less

    • Belgium
    • Pharmaceutical Manufacturing
    • 1 - 100 Employee
    • Parliamentary Council Member
      • May 2014 - Jul 2015

      The Parliamentary Council is the neutral body of EPSA that supervises and advises EPSA Team and EPSA Members. Activitities include: Supervising and advising the EPSA Team, preparing General Assembly, reviewing Membership applications, updating TORSO, reviewing documents and minutes, giving feedback to Team members about their work and progress, ... The Parliamentary Council is the neutral body of EPSA that supervises and advises EPSA Team and EPSA Members. Activitities include: Supervising and advising the EPSA Team, preparing General Assembly, reviewing Membership applications, updating TORSO, reviewing documents and minutes, giving feedback to Team members about their work and progress, ...

Education

  • Universiteit Antwerpen
    Master's degree, Pharmaceutical Sciences: Drug Development - Pharmacist
    2012 - 2017
  • Universiteit Antwerpen
    Bachelor's degree, Pharmaceutical Sciences
    2008 - 2012

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