Maité Vázquez-Manautou

Experience

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  The Children's Place

  Jan 2010 - Jan 2012

  Per Diem Associate

  Responsible for organization of store’s goods and sales to customers including achievement of seasonal sales goals.

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  Pfizer Consumer Healthcare

  Jan 2011 - Jan 2011

  Intern

  Started working in Compliance, performing assessments on process validation documents against plant’s procedures, policies and regulations. I challenged validation data packs against protocol requirements and acceptance criteria and issued reports of findings to the compliance manager. I also provided Quality Assurance support to the Accelerated Stability Program by data tabulation, evaluation and reporting of the Stability Studies.

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  BD

  Apr 2012 - Feb 2013

  Documentation Specialist

  Audit versions and structures of documents to be able to update them in SAP. Update document structures on the Bill of Materials on SAP.Document Control support

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  DuPont Pioneer

  Feb 2013 - Oct 2014

  Intern

  Inventory Intern• Responsible for executing all the production tasks of the Genetic Markers Inventory area in a timely manner.• Responsible of tracking and processing specific types of samples in the PCR process.• Continuous use of automated equipment, as well as troubleshooting when necessary.• Performing routine Preventative Maintenances and QC.• Prepare weekly metrics, keep track of jobs in order to prioritize.• Support other groups from the lab as required.• Train personnel on all the Inventory tasks, including troubleshooting and equipment use. Show less

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  CR Bard

  Oct 2014 - Mar 2015

  Documentation Specialist

  · Translation of all the Manufacturing documents and SOPs related to product transfer.· Perform the Document Control function within the validated Master Control system.· Review Change Request packets to assure compliance with the company’s policies and route for the approval process.· Work in a flexible way with constant changes in assignments and priorities.

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  Rebexa Group

  Apr 2015 - Jul 2017

  · Enhanced client product sales through efficient management of 200+ regulatory submissions in Latin America for top tier global corporations.· Collaborated and built effective relationships with internal and external stakeholders.· Spearheaded several successful regulatory intelligence projects for Latin American and Caribbean countries.· Conceptualized and authored the in-house Foreign Corrupt Practices Act policy and revised quality system protocols. · Led and performed internal policy reviews for global regulatory guidance and regulations.· Managed, prepared and reviewed regulatory document packages for submissions in Latin America.· Responsible for the timely and accurate submission of license applications for several clients, tracking and organization of documentation including maintenance of the relevant databases.· Submitted requests for justified special import permits.· Maintained and applied working knowledge of changing global regulations, regulatory standards, and protocols.· Identified updates to relevant guidance, policies, standards, and regulations and communicate to clients.· Assess product and manufacturing changes to determine regulatory impact.· Kept inventory of legal and regulatory documents used in registration projects. Show less

  • Regulatory Affairs Specialist

    Apr 2015 - Jul 2017

  • Regulatory Affairs Trainee

    Apr 2015 - Mar 2016
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  Amgen

  Aug 2017 - May 2020

  Regulatory Affairs Manager and Team Leader at Inteldot

  · Participated in cross-functional project teams as Regulatory Affairs CMC site representative, providing guidance on regulatory requirements.· Performed change management assessments; determine and communicate post-approval reporting requirements for variations related to container closure system and drug substance.· Evaluated process deviations against Module 3 sections to determine impact on approved Clinical Trial and Marketing Applications.· Supported submission preparation for successful Drug Substance Manufacturing Site Technical Transfer registration to FDA.· Redacted Module 3 sections required for submission of Drug Substance Manufacturing Site Technical Transfer for Major Markets.· Participated as Subject Matter Expert in global multidisciplinary team, providing regulatory guidance on raw materials and excipients transition to comply with Chinese Pharmacopeia and China Master File requirements.· Project Manager in charge of the development and execution of regulatory strategies to support project related post approval changes.· Completed Gap Assessment on filed container closure sections for major markets, notify and develop regulatory strategy for correction, track submissions and approvals. Show less

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  Johnson & Johnson

  May 2020 - Dec 2020

  Sr. Specialist Regulatory Affairs at ECONS Group
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  Amgen

  Nov 2021 - now

  Regulatory Affairs Manager