Mirna Libertad Vargas Ortega

Experience

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  Bristol-Myers Squibb

  Apr 2009 - Apr 2010

  Training documentation (stabilities area)

  Stability base data handling.Control of samples for analysis, elaboration the protocols analyst for stability test.Collaborate with analysts in different pharmaceutical activities (stabilities analysis and review of laboratory technical documentation)

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  St. Jude Medical

  Jan 2010 - Jan 2011

  Regulatory Affairs

  Request and reviews of technical information for the preparation of the dossier class I, II and III as modifications, renewals, preventions, corrections, procedure by traditional way and FDA equivalences.Translations: Technical files, Certificates of Analysis, and relevant documentation in accordance to the internal company’s guidelines.Implementation and training of good documentation practices, quality systems and regulations regarding distribution of medical devices to different personnel. Development and Implementation of Standard Operating Procedure (SOP´s) for different areas. Lihat lebih sedikit

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  MORE PHARMA CORPORATION

  Jan 2011 - Jan 2014

  Sr. Regulatory Affairs Chemist

  Perform of dossiers of pharmaceutics products: Allopathic Drugs (Generics, New Molecules), Medical Devices, Cosmetic, Supplements. Submit documents necessary for obtain the authorization of health authorities for release import medicines.Update and handling of legal documents, products database and permissions of import.Teamwork with Marketing, Clinical/Medical Affairs, Operations and Quality Assurance to develop new products according to the company’s new products development Review and approval of labels and promotional material according with the national standards Provide regulatory support for new products and changes to existing products by working with LATAM RA Lihat lebih sedikit

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  Laboratorios Sanfer

  Jan 2014 - Apr 2016

  Sr. International Regulatory Affairs Chemist

  Developing submission plans for perform dossier of Allopathic Drugs (Generics, New Molecules), Medical Devices, Cosmetic, Supplements.Interpreting and implementing international regulations for RA strategy to facilitate approval of new products in Latin America Countries.Evaluation, revision and feedback on the submissions Latin-American Review Scientific and technical data intended for submission ensuring the compliance with the regulatory requirements, providing guidance to marketing and design teams Lihat lebih sedikit

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  PGT Healthcare

  Apr 2016 - Jan 2018

  Regulatory Affairs Associate III

  Provide assessment and regulatory strategy for the new projects and maintenance of the product that to be launched in Central America, Colombia and Caribbean regarding OTC Products, Cosmetics and Foods.Work with the Regulatory Affairs Management to perform the day to day operational aspects of the Department such as: preparation and assembly of global regulatory submissions, post-approval variations, labeling texts according to the last version approved, review of text of the artwork, renewals and administrative submission.Teamwork with different areas as medical affairs, quality, marketing, product supply, R&DDevelop the workload for all regulatory submissions.Lead registration process for submissions in different countries, following local laws and optimizing registration approval timelines. Lihat lebih sedikit

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  Procter & Gamble

  Jun 2018 - now

  Regulatory Affairs Coordinator