Antonio Trejo Diaz

Antonio Trejo Diaz Email and Phone Number

Global Regulatory Affairs and Quality Executive - Head of Global Regulatory Affairs @ Pierre Fabre Pharmaceuticals
Antonio Trejo Diaz's Location
Acton, Massachusetts, United States, United States
Antonio Trejo Diaz's Contact Details

Antonio Trejo Diaz work email

Antonio Trejo Diaz personal email

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About Antonio Trejo Diaz

Antonio Trejo is a Regulatory Affairs and Quality Management Systems leader with broad experience on International and Global Regulatory Affairs (strategy, submission and prost approval activities and interactions with regulators across the world), Quality and Compliance (QMS, Compliance, Quality Management). Experienced leader in the LAtin America,. APAC, Europe, US and Canada Regulatory Affairs.Currently is the Head of Global Regulatory Compliance at Takeda based in the Boston MA area providing support to the Global Regulatory Affairs organization on Regulatory Compliance, regulatory processes, training, audits, inspections, labeling, Regional Regulatory Affairs, CMC and the Regulatory QMS. Mr. Trejo led the Regulatory Affairs organization at Saol Therapeutics supporting the BLA, NDA, ANDA, IND and CTA applications in the US, Canada and Global markets for Rare Disease and Neuroscience portfolio being responsible for the CMC, clinical affairs, regulatory strategy, regulatory operations and regulatory maintenance. Mr Trejo has supported regulatory strategy, CMC and post approval activities for product in the Oncology, CNS, Pain, Women’s Health, Gastro Intestinal, Migraine, Cardio vascular TA's.Mr. Trejo was Senior Director Growth Markets Regulatory Affairs for the Latin America & APAC countries and the Growth Markets region in Teva Pharmaceuticals. Mr Trejo is a Regulatory Affairs, CMC/Technical regulatory Affairs, Regulatory Conformance/Compliane and Quality Assurance professional with broad experience in the Pharmaceutical industry within a range of product categories (Specialty medicines, Biotechnology, API, OTC, Nutritional products and Medical Devices)Mr. Trejo has held positions of increasing responsibility in Regulatory Affairs and CMC/Technical Regulatory Affairs being responsible for the Mexican and Latin America region (Mx, Br, Ar, Cl, Co, Pe, Ve, Pa, Ur, Ec, Bl, and the Central America & Caribbean countries) Mr. Trejo is currently based in the USA (Miami/ Ft Lauderdale area) but also has worked in the UK and Switzerland and has a solid experience working with multi-cultural and remote groups.Mr Trejo earned a BSc in Pharmaceutical Chemistry from the Universidad Autonoma Metropolitana (Mexico City) a MSc in Pharmaceutical Sciences from the King’s College London (United Kingdom) and a MBA from Universidad Iberoamericana (Mexico City)Mr Trejo professional objective is to continue a career in the Regulatory Affairs or Quality areas at Global level.

Antonio Trejo Diaz's Current Company Details
Pierre Fabre Pharmaceuticals

Pierre Fabre Pharmaceuticals

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Global Regulatory Affairs and Quality Executive - Head of Global Regulatory Affairs
Antonio Trejo Diaz Work Experience Details
  • Pierre Fabre Pharmaceuticals
    Vice President Of Regulatory Affairs And Pharmacovigilance - Us
    Pierre Fabre Pharmaceuticals Aug 2024 - Present
    Reporting to the Pierre Fabre Pharmaceuticals US CEO. Lead the Pierre Fabre's Pharmaceuticals Regulatory Affairs and Pharmacovigilance organization supporting the Cell Therapy (allogenic), Oncology and Rare diseases pipeline. Responsible for the pre and post submission activities including regulatory clinical and CMC strategy and maintenance, compliance inspections, labeling, advertisement and promotion and safety related activities.Leading the US regulatory Intelligence and Regulatory Operations activities.
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  • Brainstorm Cell Therapeutics
    Vice President Of Regulatory Affairs
    Brainstorm Cell Therapeutics Apr 2023 - Sep 2024
    Kiryat Aryeh, Petach Tikva, Il
    • Lead the Regulatory Affairs organization at Brainstorm Cell Therapeutics on the development and registration of cell therapy and exosome products on the CNS. • Lead the interactions with the FDA and other Health Authorities in order to bring innovative therapies to patients.• Implement the Global Regulatory and Compliance strategy of the company's pipeline focusing in the US, EU, Canada and Global markets. • Implement and lead the Global Regulatory Affairs (Strategy, Project Management, CMC, Labelling, Regulatory Operations and post approval maintenance) and Compliance organizations to support the life cycle of the product pipeline from development to commercialization including Clinical, Safety and Compliance activities. Partner with CROs to support the Clinical, Safety, Regulatory and Quality and Compliance R&D activities.
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  • Takeda
    Head Of Global Regulatory Compliance - Senior Director Global Regulatory Affairs
    Takeda Nov 2020 - May 2023
    Tokyo, Jp
    • Foster, build, and maintain a culture of compliance within Regulatory Affairs to meet or exceed global health authority requirements and expectations across the product life-cycle from development to commercialization.• Lead the Regional Regulatory Compliance organization supporting the regional regulatory affairs affiliates in US, canada, Latam, Europe, Eastern Europe, China, APAC, Middle East and Affrica.• Provide global oversight for all aspects of development, communication, implementation, maintenance and execution of the Regulatory Compliance culture and strategy.• Lead all key elements of the Takeda and vendor/partner regulatory compliance and quality management system across all Global Regulatory functions and ensure alignment with global strategic initiatives and systems related to regulatory quality and compliance.• Strategic partner with the Global Regulatory Affairs organization in the development and monitoring of regulatory labelling compliance processes and systems.• Lead and manage day-to-day compliance support for GRA and/other business groups that may be appropriate, including audits and inspections and support for global regulatory compliance activities.• Partner with Takeda Quality and Compliance organization to ensure effective implementation of the Global Quality and Compliance systems within Global Regulatory Affairs• Collaborate with GRA Business Operations team members to establish compliance oversite and monitoring of any outsourced or vendor/partner relations who perform regulatory operations in accordance with Takeda GRA systems and processes.• Identify potential areas of compliance vulnerabilities and risks related to GRA functions and processes and develop strategic initiatives and/or mitigation plans to reduce risk.
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  • Saol Therapeutics
    Head Of Regulatory Affairs
    Saol Therapeutics Aug 2019 - Nov 2020
    Roswell, Ga, Us
    Lead the Global Regulatory Affairs organization supporting the registration and commercialization of the Rare Disease and Neuroscience portfolio and pipeline including NDA, ANDA and BLA registrations in the US, Canada and Global markets. Support INDA and CTA applications for the development projects.Responsible for pre and post approval submission activities including Regulatory Strategy, Regulatory Project Management, CMC, Clinical Regulatory Affairs, Regulatory Operations, Regulatory Intelligence and Labelling. Lead the Health Authority (FDA, Health Canada and Global authorities) liaison activities for development products and existing pipeline. Establish relationships with Saol’s distribution partners, commercial manufacturing partners, and other key stakeholders, providing regulatory guidance and support as required.Primary responsibility for the oversight and management of Regulatory matters related to Saol’s commercial and development product pipeline globally.Maintenance of the existing portfolio by providing strategic leadership and advice to the commercial business, manufacturing, quality, pharmacovigilance and product development.Responsible for hiring, monitoring performance, and deploying staff and regulatory teams as the portfolio evolves, and has the ability to develop people and put in place a stable environment.Champion in ensuring continuous improvement and bringing creativity to Regulatory Affairs, in line with the changes in the Regulatory Environment, able to influence these changes.
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  • Elekta
    Regulatory Affairs Director Americas (Us, Canada, Latam)
    Elekta Aug 2018 - Aug 2019
    Stockholm, Se
    Lead the Regulatory Affairs organization for the Americas region (US, Canada and Latam)Develop and execute the regulatory strategy for the registration of new Radiotherapy Medical Device products (Hardware and Software) including 510(k) and country registrations in the Americas region. Maintenance of the existing portfolio by providing strategic leadership and advice to the commercial business, partnering with Global R&D and software engineering to develop the best strategy. Lead the transition to the MDR, MDSAP, Brexit plan and Cybersecurity initiatives ensuring global compliance.
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  • Teva Pharmaceuticals
    Senior Director Growth And Emerging Markets Regulatory Affairs-
    Teva Pharmaceuticals Nov 2013 - May 2018
    Tel-Aviv, Il
    Lead the Regulatory Affairs organization in the Latin America, APAC and countries and the regional support group (+80people) including CMC for new products and maintenance. Develop and execute the growth markets regulatory strategy for the registration of new products (Global Specialty medicines including Biologics, Generics and Branded Generics) and maintenance of the existing portfolio by providing strategic leadership and advice to the commercial business, partnering with Regional and Global R&D to identify the registration requirements and develop together with medical Affairs and Clinical Operations the best clinical strategy. Develop and implement for the country and regional regulatory organization to ensure the implementation of the best regulatory practices and conformance with the country regulatory requirements. Responsible for the dossier production and maintenance for the products developed and manufactured for the region. Support the negotiation and lobbying activities with the Ministers of Health of the countries in the region and Regional Organizations. Partner with the Global CMC, Medical, Clinical, Quality and TGO groups in the organization to ensure that the regional requirements are incorporated in the Global strategies for the registration of the products. Support the M&A activities in the region. Lead the Regulatory Conformance program in the growth Markets region. Responsible for the Regulatory Operations, Regulatory Intelligence and Regulatory project Management in the region. Support a portfolio of 3000 MA's and more than 100 new product applications per year. Support the registration of product manufactured in the region for the US (including NDA, ANDA and BLA) as well as European markets. Responsible for the Labelling, Advertisement and promotion activities.
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  • Hospira
    Director Regulatory Affairs - Latin America
    Hospira Oct 2012 - Oct 2013
    Lake Forest, Il, Us
    Lead for the Regulatory Affairs organizations in the Latin America and Caribbean countries and the regional support team (+30 people). Provide strategic leadership to the Commercial business in Latin America to support the New Product registration, portfolio maintenance and M&A opportunities. Develop and support the regulatory strategy for submission at country level for regional products from development to maintenance. Coordinate the regulatory affairs personnel in the region and ensure alignment with the company global strategy and objectives. Develop and implement processes for the dossier production and roll out in compliance with the different regulations and requirements of each country in the region. Provide regulatory strategic advice to the Commercial Group, Operations, Medical, R&D and Quality organizations. Support the negotiation and lobbying activities with the Ministers of Health of the countries in the region. Partner with the CMC, Clinical, Quality and Product Support groups in the organization to ensure that the regional requirements are incorporated in the Global strategies for the registration of the products. Support the regulatory submission strategy of Biosimilar products in EU, US (including NDA, ANDA and BLA) and Latin America.
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  • Bayer
    Regional Senior Associate Director Regulatory Affairs Latin America - Consumer Care
    Bayer Feb 2010 - Oct 2012
    Leverkusen, North Rhine-Westphalia, De
    Provide strategic leadership to the Commercial business in Latin America to support the New Product registration and portfolio maintenance. Develop and support the regulatory strategy for submission at country level for both regional and global products from development to maintenance. Coordinate the regulatory affairs personnel in the region and ensure alignment with the company global strategy and objectives. Develop and implement processes for the dossier production and roll out in compliance with the different regulations and requirements of each country in the region. Provide regulatory strategic advice to the Business Units, Product Supply, Clinical, Vigilance, R&D and Quality organizations. Support the negotiation and lobbying activities with the Ministers of Health of the countries in the region. Partner with the CMC, Clinical, Quality and Product Support groups in the organization to ensure that the regional requirements are incorporated in the Global strategies for the registration of the products. Produce the Technical Regulatory sections of the Latin America dossiers (CMC)
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  • Wyeth Consumer Healthcare
    Asso. Director Plant Regulatory Conformance Latin America
    Wyeth Consumer Healthcare Jul 2007 - Jan 2010
    New York, New York, Us
    Strategic planning of the regulatory and compliance activities to establish regional processes to ensure the regulatory compliance of the Pharmaceutical and Consumer Healthcare products commercialized in Latin America. Provide regulatory support to the manufacturing and supply operations in the region ensuring the integration to the corporate CMC (Chemistry, Manufacturing & Control) Change Control process. Generate and provide the CMC documentation required in the regulatory filling to obtain the sanitary registrations in compliance with the applicable legislation in the Latin America countries. Provide technical and regulatory support to the Quality, Regulatory Affairs, Technical Services and Commercial groups in the manufacturing sites and affiliates in Latin America. Implement processes and business applications to support compliance throughout the region.
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  • Baxter Healthcare
    Regulatory Affairs Director Mexico
    Baxter Healthcare Jan 2005 - Jul 2007
    Deerfield, Illinois, Us
    Strategic planning of the regulatory and compliance activities to ensure business goals. Assure the regulatory conformance and GMP compliance of the company through the following processes: a) regulatory submission, approval and post-approval submissions of the company products (medical devices, drug products and biologics) in México and export markets b) Identify and implement with the Quality organization the strategies to assure GMP compliance and conformance with the local and applicable regulation, C) Implement the Regulatory Intelligence process and c) Implement and maintain the Medical Vigilance process. Implement and manage of the Change Control and Regulatory inspections processes. Plan and implement strategies to assure regulatory compliance from product design to post market evaluation. Responsible for the regulatory compliance with the Mexican regulations of the Biologics/vaccines sites of the Baxter group supplying product to Mexico (compile technical CMC file and handle regulatory inspections). Support the regulatory activities at the Baxter sites in Mexico (two sites) The plasma derivates, recombinant and vaccines products must be release by the Mexican MOH, therefore it was my responsibility to obtain approval for a simplified release process (ID test only) based on the compliance of the manufacturing sites (California and Vienna Austria) implementation of a Change Control system, plant inspection by the authority and maintenance of the product submission.
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  • Signa Sa De Cv (Api Manufacturer For Apotex)P
    Ra And Qa Manager
    Signa Sa De Cv (Api Manufacturer For Apotex)P Nov 2003 - Dec 2004
    Quality Assurance (Responsible to the Mexican Health Authority)-Responsibilities: Responsible for the Quality of the Active Product Ingredients manufactured by the company. Responsible for the Quality System, Materials reception and Inspection, In process control, GMP’s compliance and training, Product Release (usage decision), Audits, Vendor Assessment, Regulatory Affairs, Compliance and Validation. Assure compliance and conformance with the FDA, Canadian, European and local regulation. Receive FDA inspections. Implement a documentation system in order to prepare regulatory and post approval submission to the FDA and other international agencies. Support the product Development, New Product Introduction and Technology Transfer processes. Implementation of a continuous improvement process using lean manufacturing and six sigma tools. Support the MRP process. Regulatory support to US ,Europe, Australia and Asia
  • Signa S.A. De C.V.
    Qa Manager
    Signa S.A. De C.V. 2003 - 2004
  • Glaxosmithkline
    Several Posositions In Quality, Regulatory And New Products Development In Mexico And United Kingdom
    Glaxosmithkline Jul 1997 - Nov 2002
    Brentford, Middlesex, Gb
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Antonio Trejo Diaz Skills

Regulatory Affairs Pharmaceutical Industry Quality Assurance Gmp Regulatory Submissions Clinical Trials Regulatory Requirements Validation Product Development Fda Capa Cross Functional Team Leadership Medical Devices Pharmaceutics Sop Quality System Biotechnology Strategic Planning Pharmacovigilance Management Technology Transfer U.s. Food And Drug Administration Business Development Gcp Strategy Change Control Life Sciences R&d Vaccines Regulations Gxp Quality Auditing Global Regulatory Stratgies Public Speaking Advertising And Promotion Quality Systems Regulatory Compliance Pre Submission Regulatory Activities Post Approval Regulatory Activities Product Labelling Government Affairs Multi Cultural Team Leader

Antonio Trejo Diaz Education Details

  • King'S College London
    King'S College London
    Pharmaceutical Technology
  • Universidad Iberoamericana, Ciudad De México
    Universidad Iberoamericana, Ciudad De México
    Administration
  • Universidad Autónoma Metropolitana
    Universidad Autónoma Metropolitana
    Pharmaceutical Chemistry
  • Northwestern University - Kellogg School Of Management
    Northwestern University - Kellogg School Of Management
    General
  • King'S College London
    King'S College London
    Pharmaceutical Sciences
  • Universidad Iberoamericana, Ciudad De México
    Universidad Iberoamericana, Ciudad De México
    General
  • Kellogg Executive Education
    Kellogg Executive Education
    General

Frequently Asked Questions about Antonio Trejo Diaz

What company does Antonio Trejo Diaz work for?

Antonio Trejo Diaz works for Pierre Fabre Pharmaceuticals

What is Antonio Trejo Diaz's role at the current company?

Antonio Trejo Diaz's current role is Global Regulatory Affairs and Quality Executive - Head of Global Regulatory Affairs.

What is Antonio Trejo Diaz's email address?

Antonio Trejo Diaz's email address is an****@****lrx.com

What is Antonio Trejo Diaz's direct phone number?

Antonio Trejo Diaz's direct phone number is +121559*****

What schools did Antonio Trejo Diaz attend?

Antonio Trejo Diaz attended King's College London, Universidad Iberoamericana, Ciudad De México, Universidad Autónoma Metropolitana, Northwestern University - Kellogg School Of Management, King's College London, Universidad Iberoamericana, Ciudad De México, Kellogg Executive Education.

What are some of Antonio Trejo Diaz's interests?

Antonio Trejo Diaz has interest in Children, Business Development And Travel, Economic Empowerment, Education, Environment, New Technologies, Human Rights, Arts And Culture, Health.

What skills is Antonio Trejo Diaz known for?

Antonio Trejo Diaz has skills like Regulatory Affairs, Pharmaceutical Industry, Quality Assurance, Gmp, Regulatory Submissions, Clinical Trials, Regulatory Requirements, Validation, Product Development, Fda, Capa, Cross Functional Team Leadership.

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