Wendy Beck Email and Phone Number

Provide regulatory support for Immunoassay and Molecular Diagnostic productsCreate and submit regulatory filings to regulatory bodies and manage all regulatory body interactions through clearance/approval of the applicationSubmitted the electronic Medical Device Licence Application to Health Canada in the STED formatReceived approval of the Medical Device Licence Application with only minor questionsCreated and maintained product technical files in the Summary Technical Document (STED) formatSupported product registrations for Turkey and Argentina. Supported Software registration and inquiries for South Korea. Support China Regulatory Associates in the evaluation of the regulatory impact of proposed design changesSubmitted 180 day submission to FDA for the Access 2 3.4.2 software changes, responded to all agency inquiries and gained approval of the applicationParticipate as a Core Team member providing regulatory advice and strategy to the multi-functional team for maintaining regulatory complianceEvaluate product design changes for regulatory impact and participate in Design Change teams from change identification through Design Transfer ReviewEvaluate planned deviations and manufacturing deviations for effect on regulatory complianceCreated a 510(k) submission Table of Contents in the IMDRF format in anticipation of a 510(k) filing and to use as a planning tool for submission creationProvide regulatory advice on product compliance and field action strategy, based on solid understanding of current regulations and practices, identify appropriate strategy for customers and regulatory bodiesCoordinate and manage the post-market field action reporting to Regulatory Bodies Regulatory voting member for CAPA Review Board and Change Control BoardMentor regulatory associates to assist in their regulatory knowledge development and functional team members to increase their understanding of regulatory requirements and strategy

Responsible for regulatory application submissions, safety reporting, Chemistry, Manufacturing and Controls, labeling, informational amendments, protocol amendments, investigational drug application amendments / notifications and study reportsManaged the planning and filing of 2 initial Investigational New Drug Applications in the electronic CTD format and the subsequent application maintenancePlanned and filed 2 Canadian Clinical Trial Applications and the subsequent application maintenance (Phase 1 and Phase 2)Directly involved with the Contract Research Organization for the creation, review and filing of Clinical Trial Applications in Poland and Hungary and the subsequent application maintenanceLead internal regulatory contact for three development productsPrimary contact with regulatory agencies for three development productsReviewed and analyzed proposed internal changes to applications for regulatory implications and filing strategiesOversaw and monitored proposed regulatory changes to applications from the FDA and other agencies and provided management with the potential impact of the changesProvided regulatory advice to development teams and ensure the quality control of regulatory documentsReviewed all submissions for regulatory content and compliance and applied solid technical knowledge of regulations and guidelines in order to assess applicability of a documentMaintained compliance with regulatory commitments in regulatory applicationsFacilitated effective communication between government agencies and the project teamWrote FDA correspondence and agency meeting minutes including interpretation of discussions, outcomes and future action itemsResearched and communicated potential regulatory issues and initiatives that could affect and/or streamline the development process for a projectParticipated in regulatory strategy meetings and served as a representative on project teamsMentored junior level Regulatory Affairs colleagues

Performed Chemistry, Manufacturing and Controls content review and overall format review of Investigational and New Drug submissions to the FDAManaged the development of new drug labeling compliant with FDA guidances and the Physician Labeling Rule formatManaged, drafted, reviewed and submitted routine and planned Investigational and New Drug Application submissions, coordinating with involved departments on submission strategyManaged the maintenance of 2 approved New Drug ApplicationsCoordinated the drafting and submission of a New Drug Application in the CTD formatCreated, bookmarked and linked documents of hybrid CTD and CTD applications on electronic mediaLed and participated in functional teams for drug development and strategyAdvised and consulted with internal staff and scientific consultants and vendors who contributed to submissions, ensuring that information complied with FDA and appropriate health authority guidancesServed as liaison to FDA for Company. Initiate, coordinate and respond to FDA contactsPrimary internal regulatory contact and liaison for contract manufacturers on Chemistry, Manufacturing and Controls issues providing regulatory advice on product compliance, based on solid understanding of current regulations and practicesMonitored the effect that proposed changes in regulations may have on current and future development strategies remaining current on regulatory requirements and initiatives, sharing the latest information or changes with co-workersEvaluated the regulatory impact of proposed changes within the Investigational and New Drug applications against applicable guidelines and provided rationale for submissionReviewed changes in Chemistry, Manufacturing and Controls related manufacturing or quality control SOPs and documents to ensure compliance with approved versions in Investigational and New Drug Applications with current regulationsProvided support to international licensees for registering marketed products