Anu Davies Email and Phone Number
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Dynamic, progressive, adaptive leader with 25 years’ experience within the pharmaceutical industry; specializing in global clinical supplies provision, strategic outsourcing & CMO partnership development, selection, set up & deployment of RTSMs.Key Skills Expertise in managing people, data, suppliers, risks and financial resources. Committed to leadership and fostering strong relationships; collaborating with staff, team members and stakeholders to achieve significant results. Results driven; taking strategic ownership and driving accountability, maintaining a flexible perspective coupled with an analytical and logical approach.Diverse experiences with increasing seniority in US, EU and Japanese led pharma, small to mid-sized organizations.Technical Competencies Global Clinical Supply Chain Deployment Interpretation and Translation of Complex Trial DesignComparator Sourcing Forecasting Material and BudgetsRTSM Selection, Testing and Deployment CRO and CMO partnershipsRegulatory CMC IND/IMPD requirements Blinding TechniquesAccountability, Returns and Destruction EU Qualified Persons ReleaseAncillary and Concomitant Items Controlled Temperature MonitoringRandomization and Stratification Shelf-Life ManagementSupporting IMP Stability Right Time Labeling SolutionsReturn and Destruction Practices Import/Export ConsiderationsGlobal Depot Network Set up Pharmacy ManualsInvestigator Meeting Training Site SupportContemporaneous Dispensing SOP writingGMP procedures and audits EU CTR Annex 6 labelling requirements
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Consultant And Business OwnerWaterside Pharma Consultancy Feb 2018 - PresentGroton, Massachusetts, UsMultiple engagements in Global Clinical Supply Chain Management.
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Head Cmc Submissions, Senior DirectorShire Aug 2014 - Jan 2018Tokyo, Jp, JpDeveloped business process and stakeholder engagement to effect harmonization, standardization, operational efficiencies in the area of CMC Regulatory Submissions Management. Ensure infrastructure, communication pathways, resources, tools, training and performance metrics are established and managed. Following Shires acquisition of Baxalta serving as the lead business owner for Shires CMC submissions process and tools enabling Shire to deliver high quality CMC submission components for global filings across the product portfolio to agreed timelines. -
Senior Director, Product DevelopmentShire Jan 2012 - Aug 2014Tokyo, Jp, JpResponsible for supporting the Pharmaceutical Sciences Department with expertise in drug synthesis, drug formulation, product manufacturing, regulatory and analytical support, including development, validation, and data review for drug substances and drug products, for the development of global products
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Director, Regulatory AffairsShire Jan 2011 - Dec 2011Tokyo, Jp, JpSecondment in Reg Affairs - Embarked upon a 12 month secondment into the Global Regulatory Strategy team which included insights into developing regulatory strategy for; development compounds (filing CTAs and IMPDs, substantial amendments, attending pre IND meeting with the FDA), commercialised licenced products (filing post approval variations, line extensions) and a major EU MAA filing for an NCE.
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Director Clinical SuppliesShire Feb 2004 - Dec 2010Tokyo, Jp, JpServing as the functional leader for complex Global Clinical Supply projects, leading regional and global CS staff for the planning and fulfilment of Shire R&D business critical projects. Developing and implementing programs to enhance local and global Clinical Supplies group functioning and growth. Clinical Supply project budgetary responsibility. Representing Global Clinical Supplies/Pharmaceutical Sciences group for Corporate and/or R&D global initiatives.
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Clinical Supplies ManagerTakeda Pharmaceuticals 2001 - 2004Tokyo, JpResponsibility for providing a complete materials management service for the European Development teams. Including product sourcing, production scheduling, identifying need for associated stability data, departmental resourcing, budget forecasting, clinical pack design and timely distribution, vendor management and GMP adherence. -
Clinical Supplies Team LeaderRoche May 1999 - Oct 2001Switzerland 🇨🇭 , ChManager of a GMP unit dedicated to the packaging and labelling of supplies for local phase I studies and the UK arm of global studies. Key responsibilities included; managerial responsibility for the 5 staff members, management and maintenance of a GMP facility, generating batch documentation and resource planning and allocation. -
PharmacistNhs Jun 1996 - May 1999GbA ward based pharmacist with responsibility for providing a bedside pharmaceutical service. Encompassing aspects such as, provision of drug information for other health care professionals, patient counselling, advising on consultant ward rounds, formulary maintenance and prescription checking.
Anu Davies Skills
Anu Davies Education Details
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University Of NottinghamPharmacy
Frequently Asked Questions about Anu Davies
What company does Anu Davies work for?
Anu Davies works for Waterside Pharma Consultancy
What is Anu Davies's role at the current company?
Anu Davies's current role is Clinical Supply Chain Consultant.
What is Anu Davies's email address?
Anu Davies's email address is ad****@****ire.com
What is Anu Davies's direct phone number?
Anu Davies's direct phone number is +178148*****
What schools did Anu Davies attend?
Anu Davies attended University Of Nottingham.
What are some of Anu Davies's interests?
Anu Davies has interest in Science And Technology.
What skills is Anu Davies known for?
Anu Davies has skills like Pharmaceutical Industry, Gmp, Fda, Regulatory Affairs, Regulatory Submissions, Clinical Development, Clinical Trials, Drug Development, Formulation, Validation, Ind, Regulatory Requirements.
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