Laura Cotrino

Regulatory Affairs Manager at ACARPIA Farmaceutici S.r.l.
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Contact Information
us****@****om
(386) 825-5501
Location
Milan, Lombardy, Italy, IT
Languages
  • Italiano Native or bilingual proficiency
  • Inglese Professional working proficiency

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Credentials

  • Dry Suit Diver
    PADI
    Nov, 2017
    - Nov, 2024
  • Open Water Diver
    PADI
    Jul, 2017
    - Nov, 2024

Experience

  • ACARPIA Farmaceutici S.r.l.
    • Italy
    • Pharmaceutical Manufacturing
    • 1 - 100 Employee
    • Regulatory Affairs Manager
      • Oct 2022 - Present

      - Responsible for overall supervision of the team and for all the activities to support and grow the business, interact with local partners and solve critical issues. - Responsible for communications with Health Authorities and third parties. - Evaluation of regulatory strategy and requirements to register new products in EU and extra-EU countries to ensure introductions of new products and line extensions according to business plan.- Management of all the regulatory issues relating to the medicinal products for Italy and other EU and extra-EU countries relating to Marketing Authorization Applications, Variations, Renewal and preparations of all the related documents. - Management from a regulatory point of view the review of promotional material (member of AFI IMS Group) in order to be in line with the legislation.- Management of the P&R dossier (preparation/submission/evaluation/negotiation) for Italy and other EU/extra-EU countries. - Monitoring of pharmaceutical expenditure for Italy and Greece (Payback/Clawback and Rebates). -Attendance in relevant cross-functional activities where regulatory input is needed (due diligence for the acquisitions of new products, qualification for new suppliers, artwork preparation and review, and new business projects). Show less

    • Regulatory Affairs Specialist
      • May 2019 - Oct 2022

      - Management of the dossier from the preparation up to the submission and registration for the registration of medicinal products in Italy, EU and extra-EU countries.- Preparation and maintenance of packaging material and patient information leaflets and management of artworks.- Management of the review of promotional and non-promotional materials.- Management of pricing and P&R dossier for the Italian market and other EU/extra-EU counties.- Management of congress and conference files.- Management of Quality and Clinical Modules from a regulatory point of view.- Participate in relevant cross-functional activities where regulatory input is needed. Show less

  • Sanofi
    • France
    • Pharmaceutical Manufacturing
    • 700 & Above Employee
    • Regulatory Affairs Officer
      • Aug 2018 - Apr 2019

      • Variations for MRP/DPC, Centralized or National products• Drafting, evaluation and management of the "dossier" (in CTD and eCTD format) of the drugs• Safety labelling variations and CMC variations• Revision and translation of product information (SPC, leaflet, label) in compliance with current legislation• Control of texts (labels, leaflets and SPCs) before and after the approval of AIFA and before their internal / external dissemination, preparation of all final steps of disclosure of communications.• Updating of company databases and applications used by regulatory authorities• Submission AIFA Front End, AIFA Fees Payment System Show less

    • Regulatory Affairs Officer Intern
      • Feb 2018 - Jul 2018

      • Variations for MRP/DPC, Centralized or National • Updating of company databases and applications used by regulatory authorities• Submission AIFA Front End, AIFA Fees Payment System

  • Licofarma Srl
    • Italy
    • Personal Care Product Manufacturing
    • 1 - 100 Employee
    • Thesis internship
      • Mar 2017 - Sep 2017

      I did a thesis internship where I carried out quantitative and qualitative analysis work on lycopene extracts. Abilities to make an analysis with HPLC. I did a thesis internship where I carried out quantitative and qualitative analysis work on lycopene extracts. Abilities to make an analysis with HPLC.

  • Farmacia Malcangio
    • Farmacista
      • Oct 2016 - May 2017

      900 hours of pre-graduate curricular internship -Professional ethics -Technical-administrative management of the pharmacy related to the organization, disengagement and execution of the pharmaceutical service on the basis of current legislation, national and regional -Coaching of the pharmacist in the purchase, possession and dispensation of medicines -Services provided within the National Health Service -Information and education for the health of the population, aimed at the correct use of drugs and prevention -Use of information sources available at the pharmacy or accessible at centralized facilities -Management of products other than medicines, similar to these and in any case with health value -Use of electronic support systems for the identification and storage of professional and business data Show less

Education

  • Università Cattolica del Sacro Cuore
    Corso di Master Universitario di 2° livello-CMU2, Sviluppo preclinico e clinico del farmaco: aspetti tecnico-scientifici, regolatori ed etici
    2018 - 2019
  • Università degli Studi di Urbino Carlo Bo
    Abilitazione alla professione di Farmacista, Farmacia
  • Clinical Research Educational Training - CRES (Roma)
  • Università degli Studi di Urbino Carlo Bo
    Master degree, Farmacia
    2012 - 2017
  • Liceo Classico “Virgilio” Lecce
    2007 - 2012

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