B

Belen Just Tiscornia

About

Detail

Buenos Aires, Argentina

Timeline

work
Job

Résumé

Jobs verified_user 0% verified
  • D
    Of Counsel Life Sciences Consultant
    DLA Piper Argentina
    May 2023 - Current (3 years 3 months)
    Regulatory Intelligence. Support in pharmaceutical products, biological products, cosmetic products, medical devices, vaccines, and food supplements, Biologics, Biosimilars, and Clinical Trials.
  • Freyr Solutions
    Head LATAM Regulatory Affairs (Consultant
    Freyr Solutions
    Mar 2022 - Dec 2022 (10 months)
    Regulatory support for the submission, maintenance, and post-marketing variations of cosmetic products. Correction of promotional material and artwork Building multidisciplinary work teams Regulatory Affairs Intelligence
  • D
    Regulatory Affairs Manager LATAM
    DNDi Drugs for Neglected Diseases Initiative
    Jun 2021 - Mar 2022 (10 months)
    Perform visits remotely according to the foreseen applicable procedures and timeframes Interact with the Trial Start-up team and support collecting the documents or information necessary for the ethical and administrative submission Interpret complex ANMAT – COFEPRIS -ANVISA and other government agency regulations to inform development plans and regulatory positioning. Coordination of activities with LATAM sponsors Design of a strategic and harmonized submission plan for the LATAM countries involved. Adjustment of SMPC by including modifications based on ongoing clinical studies Member of global submission committees. Meetings with Paho Head of Regulatory Affairs in the COFEPRIS standards modernization project
  • I
    Independent Consultant in Regulatory Affairs
    Aug 2017 - Current (9 years)
    Design and implementation of regulatory strategies. Creation of multidisciplinary work teams comprised of professionals from the EU, the Americas, etc. Support internal and external audits, staff training, and development of controlled quality documentation Manage and prepare complex regulatory submissions, including drafting, review, and approval of submission contents, which will require interaction with cross-functional teams and external clients to ensure timely and quality execution Provide regulatory impact assessments to changes to project teams and senior management, and recommend strategies and regulatory courses of action Lead the preparation for regulatory meetings (pre-Investigational New Drug Application [IND], pre-Clinical Tri
  • S
    Regulatory Affairs Mgr
    Savant Pharm S.A
    Dec 2014 - Jun 2017 (2 years 7 months)
    Act as a thought partner and enable the Head of Regulatory Affairs by providing quality regulatory input and a strategic perspective to internal business partners. Serve as an internal consultant and subject matter expert to guide regulatory strategy, policy interpretation, and risk mitigation efforts in partnership with GRLs. Responsible for Regulatory portfolio registration in Latin America and Africa. Design of an annual strategic plan Design the strategy to successfully transfer products (NAF and Szama) Analyze the impact of new regulations for Argentina, the LATAM zone, and Africa. Facilitate internal approvals of artwork assets following established Standard Operating Procedures (SOPs) and document control requirements. Build, mentor,
  • S
    Affiliate quality officer
    Sanofi-Aventis Argentina
    Jul 2006 - Dec 2014 (8 years 6 months)
    Submission, follow-up, and obtaining the approval of pharmaceutical products, biological products, cosmetics products, medical devices, vaccines, IVD, and food supplements. Review of the CTD and, in particular, of the CMC to submit and obtain approval for a new product Variations, Third parties approved. Analyze the impact of new regulations for Argentina and the Southern Cone. Responsible for the transfer of the product portfolios of companies acquired Coordinate renewal of the annual plan for Argentina and the LATAM zone. Regulatory support for LATAM countries Lead and manage commercial artwork projects by evaluating regional Regulatory project trackers and aligning with Supply Chain production packaging schedules across multiple manufact
  • L
    Technical assistant.
    Laboratorio Elea S.A.C.I.F y A.
    Apr 2001 - May 2005 (4 years 2 months)
    Imports of medicines and medical devices, submission and release of batches to ANMAT Imports of psychotropic drugs, submission, follow-up, and obtaining of import and export certificates Coordination of packaging implementation (changes, approvals)