Valentina Cicala

Regulatory Affairs Manager at BETAFARMA S.P.A.
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Contact Information
us****@****om
(386) 825-5501
Location
IT
Languages
  • Italiano Native or bilingual proficiency
  • Inglese Professional working proficiency
  • Francese Elementary proficiency
  • Spagnolo Elementary proficiency

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Credentials

  • Creating Great First Impressions
    LinkedIn
    Aug, 2019
    - Nov, 2024
  • Job Searching, Interviewing, and Negotiating Salary
    LinkedIn
    Aug, 2019
    - Nov, 2024
  • Abilitazione professionale: Biologa senior sezione A
    Ordine Nazionale dei Biologi
    Sep, 2015
    - Nov, 2024
  • IELTS Academic
    British Council
    Jun, 2014
    - Nov, 2024

Experience

    • Italy
    • Cosmetics
    • 1 - 100 Employee
    • Regulatory Affairs Manager
      • May 2020 - Present

      - Review raw material and ingredient compositions for regulatory conformity - Generate and maintain technical dossier for all products necessary for registration purposes - Review artwork for compliance - Ensure all needed requirements are received from clients - Create INCI for packaging artwork, label and claims - Collect and update product's documents such as SDS, COA, Spec. - Create PIF, SDS, IS etc. of finished products - Use listening, problem-solving, and multi-tasking skills to successfully handle multiple requests while detailing document activity - Stay abreast of current and new Cosmetic regulations (ECHA, REACH, Cosmetica Italia and other Autority) and guidelines and ensure adherence throughout product lifecycle - Communicate the impact of changes in the regulatory environment to the Business and modify strategies accordingly - Interface with internal and external partners, and stakeholders such as R&D, Production, Supply Chain, Regulatory, and Purchasing, to ensure tight alignment and synchronization among Regulatory strategies, product development and business goals

    • Italy
    • Personal Care Product Manufacturing
    • 1 - 100 Employee
    • Regulatory Affairs Specialist - Cosmetics, Flavours & Fragrances and Nutra
      • Mar 2020 - May 2020

      - Technical and regulatory evaluation of raw materials - Serves as regulatory resource for external suppliers and internal partners, including R&D, Commercial, etc. to address regulatory questions/issues - Oversees completeness of legal compliant regulatory reviews, confirmations, statements, documents and forms - Provide an accurate and timely response to customer requests - Monitor and stay current with global regulatory activity - Participate in fair and seminar for cosmetic and nutritional purpose - Preparation of CoA, Product Specification, Long term declaration, and other technical documents - Create and maintain an SDS (Safety Data Sheet) database for all products - Ensure compliance of product MSDS with global requirements - Produce regulatory declarations and certificates (animal testing, Halal, Origin, ISO 16128 etc) - Manages the impact of changes in regulations with respect to products and documents.

    • Italy
    • Personal Care Product Manufacturing
    • 1 - 100 Employee
    • Regulatory Affairs Officer
      • Oct 2019 - Mar 2020

      - Review raw material and ingredient compositions for regulatory conformity based on FDA/EU/CANADA/PROP 65 compliance/ASEAN/CINA/MERCOSUR - Generate and maintain technical dossier for all products necessary for registration purposes - Review artwork for compliance and collaborate with the Creative team for revisions as needed of clients - Ensure all needed requirements are received from clients (black list, special requests etc) - Create INCI for packaging artwork, label and claims - Collect and update product's documents such as SDS, COA, Spec. - Create PIF, SDS, IS etc. of finished products - Use listening, problem-solving, and multi-tasking skills to successfully handle multiple requests while detailing document activity - Stay abreast of current and new Cosmetic regulations (ECHA, REACH, Cosmetica Italia and other Autority) and guidelines and ensure adherence throughout product lifecycle - Communicate the impact of changes in the regulatory environment to the Business and modify strategies accordingly - Interface with internal and external partners, and stakeholders such as R&D, Production, Supply Chain, Regulatory, and Purchasing, to ensure tight alignment and synchronization among Regulatory strategies, product development and business goals - Collaborate with clients on regulatory procedures, requirements and potential barriers

  • Factoryspa srl
    • Brembate, Lombardia, Italia
    • Senior Regulatory Affairs Officer
      • Apr 2017 - Jul 2019

      - Draft and updat technical dossiers for cosmetic products (technical data sheets, safety tests, etc.) - Plan of tests on the finished products (challenge, patch, etc.) - Registration of products in the CPNP portal - Guarantee compliance regulation of labels and packaging according to EC Regulation No. 1223/2009 - Give technical support to the marketing - Control of the physical and chemical parameters of finished cosmetics products - Quality control of packaging and the finished products - Search for new active substances - Plan and monitoring development of new products - Edit and making products presentations

    • Nutritionist
      • Sep 2015 - Jul 2018

  • Dolce&Gelato Bio
    • Amsterdam, Paesi Bassi
    • Customer Service Sales Assistant
      • Jul 2015 - Sep 2015

      Improving English skills Improving English skills

    • Research Assistant Internship
      • Jun 2013 - Oct 2014

      - MSc project:“Relationship between plasma fatty acids profile and liver fat content after an high monounsatured fat diet treatment” - Elaboration of a new of plasma fatty acid extraction protocol - Evaluate the effects of a diet rich in MUFA fatty acids on non- alcoholic fatty liver disease - Preparation of serum samples - Gas chromatography (GLP) - Solid phase extraction (SPE). - Processing data by SPSS statistical program - Development scientific paper for publication. The work was published on scientific journal Diabetologia

    • Research Assistant Internship
      • Mar 2012 - Jun 2012

      - BSc project: “Characterization of different types of San Marzano tomato by SSR” Characterization of different varieties of tomato San Marzano using molecular biology techniques - DNA extraction - PCR analysis - Electrophoresis and capillary electrophoresis analysis - Processing data by statistical program - BSc project: “Characterization of different types of San Marzano tomato by SSR” Characterization of different varieties of tomato San Marzano using molecular biology techniques - DNA extraction - PCR analysis - Electrophoresis and capillary electrophoresis analysis - Processing data by statistical program

Education

  • Università degli Studi di Milano
    Corso di perfezionamento, La gestione dei dispositivi medici e cosmetici: aspetti regolatori (9ZR)
    2020 - 2021
  • ALMA LABORIS Business School
    Diploma di specialista in Affari Regolatori, Regulatory Affairs
    2019 - 2019
  • Comunicazione farmaceutica
    High specialization course in Regualatory affairs
    2017 - 2017
  • Università degli Studi di Napoli 'Federico II'
    Master's degree, Human Nutrition
    2012 - 2014
  • Università degli Studi di Napoli 'Federico II'
    Bachelor's degree, Biotechnology
    2008 - 2012
  • Università degli Studi di Milano-Bicocca
    Specialization course, La comunicazione web e il marketing digitale
    2019 - 2019
  • Politecnico di Milano
    Specialization course, Working in Multidisciplinary Teams
    2019 - 2019

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