Jose A. Colon

Experience

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  Bristol-Myers Squibb

  May 1988 - Jul 1999

  Documentation and Regulatory Leader

  • Manage/coordinate/collaborate in the implementation of new processes and/or technology transfer projects anticipating all technical, operational and regulatory documentation needs.• Compile and/or review technical documentation necessary for implementing new and/or modified processes at the industrial scale.• Compile and submit to the regulatory groups the information/documentation requirements necessary for the registration of drug master files, NDA amendments, supplements and annual updates to the domestic (FDA) and international regulatory agencies.• Administrator of the change control program for the Bulk Pharmaceutical operations.• Maintain day-to-day liaison and communication with a variety of personalities from multiple disciplines (e.g. Manufacturing, QC/QA, Regulatory, Process Development, Safety, Environmental Affairs, Production Planning, New Products Planning, Technology Transfer Groups, etc.) involved in the chemical production or development of new products.• Analyze, prioritize and allocate resources required for the timely creation, audit and/or approval of Master Batch Records / SOP's for the bulk manufacturing areas.• Maintain control of the primary, operational and regulatory documentation for the bulk pharmaceutical operations.• Provide direct support to the validation activities for the bulk operations.• Active participant on BMS committees dealing with Cost Improvement Projects, Waste Minimization, Industrial Toxic Program, Materials Review Board, and Technology Transfer committees. Show less

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  Wyeth Pharmaceuticals, Inc.

  Jul 1999 - Jan 2008

  • Provide regulatory conformance leadership and direction to the Quality Operations and Plant Directors, including review of manufacturing deviations and change controls.• Assure that plant documentation is continuously in conformance with regulatory documentation filed with worldwide Regulatory Agencies.• Represent Regulatory Conformance and provide regulatory guidance on Site Quality Council.• Lead all post-filing activities for the site products (compilation of NDA/ANDA supplements, annual reports and response to deficiency letters). Responsible for assembling submission documentation for new product registration at domestic and international markets.• Responsible for defining, coordinate, execute and fast-track registration strategies/activities for modifications to the registered products, in a partnership relation with Corporate Domestic and International Regulatory Groups.• Analyze, prioritize and allocate resources for the support of registration and license renewal activities for the existing and emerging international markets.• Coordinate feedback from worldwide regulatory affiliates for manufacturing (CMC) changes and fast-track registration activities required.• Direct interaction with regulatory auditors during FDA and MCA inspections.• Global Regulatory CMC Product Leader (GRCPL) for the Zosyn/Tazocin Brand. Accountable for regulatory strategy and global registration activities for the Zosyn/Tazocin drug product lifecycle. • Manage work activities for 4 scientists supporting the Wyeth Carolina operations Show less • Provide regulatory / compliance leadership, direction and support to the manufacturing operations.• Responsible for defining, coordinate, execute and fast-track registration strategies/activities for modifications to the registered products, in a partnership relation with Corporate Domestic and International Regulatory Groups. • Lead all post-filing activities for the site products (compilation of NDA/ANDA supplements, annual reports and response to deficiency letters). Responsible for assembling submission documentation for new product registration at domestic and international markets.• Analyze, prioritize and allocate resources for the support of registration and license renewal activities for the existing and emerging international markets.• Provide regulatory evaluation for investigations associated to manufacturing deviations and troubleshooting activities.• Manage pre-approval inspection site readiness activities for all new drug applications or supplements.• Direct interaction with regulatory auditors during FDA and MCA inspections.• Commitment tracking toward timely completion and implementation of corrective and preventive actions for all audit and cGMP observations associated to the Technology Department.• Provide technical regulatory guidance to Technical Services, Manufacturing and QC/QA personnel. Show less • Analyze, prioritize and allocate resources required for the timely creation and implementation of qualification and validation protocols plus associated reports.• Oversee the execution of the Validation Master Plans for the Piperacillin and Parenterals Business Units.• Provide validation recommendations for all changes to validated/qualified equipment and processes.• Provide leadership and direction for development and optimization of manufacturing processes.• Provide prompt and sound technical support / troubleshooting for day-to-day production activities.• Participate in investigations associated to manufacturing deviations and troubleshooting activities.• Direct interaction with regulatory auditors during FDA and MCA inspections to the Piperacillin and Parenterals facilities to present/defend validation documentation.• Provide leadership and direction for technology transfer projects from R&D and other WA manufacturing sites to WA Lederle, Carolina. Manage and coordinate the implementation of new processes and/or technology transfer projects anticipating all technical, operational, validation and regulatory needs.• Maintain day-to-day liaison and communication with a variety of personalities from multiple disciplines (e.g. Manufacturing, QC/QA, Regulatory, Process Development, Safety, Environmental Affairs, Production Planning, Strategic Outsourcing, New Products Planning, Technology Transfer Groups, etc.) involved in the production and/or development of new products.• Provide support/mentoring on regulatory guidelines and registration requirements as needed for the different domestic and international registration projects.• Manage work activities for 26 scientists supporting the Piperacillin and Parenterals Business Units. Show less • Provide regulatory / compliance leadership, direction and support to the manufacturing operations.• Responsible for defining, coordinate, execute and fast-track registration strategies/activities for modifications to the registered products, in a partnership relation with Corporate Domestic and International Regulatory Groups. • Lead all post-filing activities for the site products (compilation of NDA/ANDA supplements, annual reports and response to deficiency letters). Responsible for assembling submission documentation for new product registration at domestic and international markets.• Analyze, prioritize and allocate resources for the support of registration and license renewal activities for the existing and emerging international markets.• Provide regulatory evaluation for investigations associated to manufacturing deviations and troubleshooting activities.• Manage pre-approval inspection site readiness activities for all new drug applications or supplements.• Direct interaction with regulatory auditors during FDA and MCA inspections.• Commitment tracking toward timely completion and implementation of corrective and preventive actions for all audit and cGMP observations associated to the Technology Department.• Provide technical regulatory guidance to Technical Services, Manufacturing and QC/QA personnel. Show less

  • Associate Director, Regulatory Conformance

    Jun 2005 - Jan 2008

  • Regulatory and Compliance Manager

    Sept 2003 - Jun 2005

  • Technology Manager

    Jan 2001 - Aug 2003

  • Regulatory and Compliance Manager

    Jul 1999 - Jan 2001
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  Wyeth, Pharmaceuticals, Inc.

  Feb 2008 - Oct 2009

  Director, Regional Regulatory Conformance – Latin America

  • Ensure that marketed products within the Latin America region are manufactured in accordance with all relevant regulatory documentation and requirements.• Manage Regulatory Conformance organization at Wyeth's global manufacturing facilities in the region.• Manage Global Product Conformance (GPC) project deliverables within regional plants to meet timelines.• Responsible for defining, coordinate, execute and fast-track registration strategies/activities for CMC documentation (submission/variation) for successful registration process: consistency and quality of format, content and process of CMC documentation.• Project manager of CMC regulatory submissions within the Latin America region. Support affiliates with submission and approval process.• Regulatory management of change control to MA and plant documentation within the Latin America manufacturing sites and affiliates. Coordinate feedback from regulatory affiliates for manufacturing (CMC) changes and fast-track registration activities required.• Administrate and maintain the technical dossiers or CMC related documents for the products manufactured/packaged/tested at the Latin America region.• Manage work activities for 12 resources supporting the Regulatory Conformance activities for the Latin America region. Show less

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  Pfizer

  Oct 2009 - Aug 2012

  Director, Americas Hub Lead - GCMC, Regional Regulatory CMC Conformance Hubs

  • Lead team of professionals responsible for regional/local management of lifecycle submissions in US, Canada and Latin America, including: market applications, post-approval submissions/variations, renewals and annual reports, for pharmaceutical small molecules, biological/vaccines, consumer and nutritional products.• Lead submission strategy for execution of lifecycle submissions associated to management of CMC changes originating at manufacturing sites or affiliates toward maximizing efficiency, quality and rate of submission approvals by Boards of Health.• Lead assembly of lifecycle submissions for markets under responsibility and coordinate with affiliates for timely and effective submission of changes to the Boards of Health.• Manage work activities for 25 resources supporting the Americas Hub activities for the North America & Latin America regions. Show less

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  Genentech, A Member of the Roche Group

  Sept 2012 - Sept 2016

  Regulatory Group Director, Pharma Technical Regulatory Regional Hubs

  Regional management of CMC lifecycle submissions and affiliate offices interactions for Roche products at regional level in Asia Pacific, Latin America and Eastern Europe/Middle East/Africa

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  Merck, , currently appointed for Organon & Co.

  Oct 2016 - Jun 2021

  Lead Site CMC Teams across Merck/MSD manufacturing sites in the Americas Region. Regional management of CMC lifecycle submissions and affiliate offices interactions for all Merck products as well as new product registrations at regional level in Asia Pacific, Latin America and Europe/Eastern Europe/Middle East/Africa.

  • Exec Dir, Reg CMC Global Operations & Conformance at Merck, currently appointed for Organon & Co.

    Feb 2021 - Jun 2021

  • Director, Regulatory Affairs CMC - Americas Site CMC Head

    Apr 2018 - Feb 2021

  • Director, Regulatory Affairs CMC - International Program Management

    Oct 2016 - Apr 2018
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  Organon

  Jun 2021 - now

  • Associate Vice President, Reg CMC Global Operations & Conformance

    Jul 2023 - now

  • Exec Dir, Reg CMC Global Operations & Conformance

    Jun 2021 - Jul 2023