Vicki Hayes

Experience

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  PAREXEL

  Jan 2004 - Jul 2004

  Business Associate, Business Operations,
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  Eli Lilly and Company

  Jul 2004 - Apr 2007

  Regulatory Scientist, European Regulatory Affairs
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  Amgen

  Apr 2007 - Mar 2012

  EU Regulatory Group Lead - Oncology

  • Senior Manager, European Regulatory Affairs

    Jan 2011 - Mar 2012

  • Senior Manager, European Regulatory Affairs

    Nov 2009 - Jan 2011

  • Manager, European Regulatory Affairs

    Apr 2007 - Nov 2009
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  Amgen

  Mar 2013 - Dec 2013

  Director, European Regulatory Affairs

  EU Regulatory Group Lead - OncologyAs EU Regulatory Group Lead for Haematology/Oncology, provided oversight and regulatory strategic support across product portfolio (marketed and development products) as well as line management of Oncology/Haematology EU Regulatory group. As EU regulatory affairs lead directly responsible for 3 early phase oncology therapeutic molecules.Provided strategic input into development and represented regulatory function in cross functional development teams. Led implementation of regulatory strategy in the region.Successfully led recruitment activities, allocated projects according to resource and capabilities, provided coaching to regulatory professionals, administration of annual compensation planning.Led interactions with local affiliates and international commercial team to ensure business needs taken into consideration with the aim of obtaining acceptable labelling in all markets. Show less

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  DLRC Regulatory Consultancy

  Feb 2014 - May 2023

  As Director of Consulting, I was responsible for the oversight of the consulting provision. Reporting to the CEO, I supported the growth and development of the company by giving strategic direction to the Board to ensure the company achieves its objectives with specific focus on ensuring the quality, efficient delivery and profitability of the consultancy provision.In this role, I was responsible for the the Regulatory Affairs Team, Medical Writing and Regulatory Operations Teams as well as specialist business areas including ATMP and CTR expert groups. Throughout I maintained a 'hands on' role, and was Engagement/Project Lead for a variety of regulatory projects for a broad spectrum of clients (including small-medium Biotech companies and not for profit organisations). Key projects included the submissions of an EU centralised MAA as well as development of Paediatric Investigation Plans, Orphan drug Designations and Scientific Advice Briefing packages.Partnered with Business development and Sales and Marketing to provide experts to support work on proposals and provide insights into current markets and potential avenues for future work.Was involved in recruitment across all areas of the business and as key member of Resourcing team oversaw the assignment of resourcing of all projects. Show less Board Director and Team Leader for Regulatory Affairs and Medical Writing Teams (as above Director of Consulting). As Project Lead provided regulatory strategic advice on guidelines, legislation and procedures to variety of clients on assigned projects. Managed team of assigned consultants, budgeting and invoicing processes. Led all aspects of submissions - writing and preparation, review & finalization. Liaised directly with the Regulatory Authorities (EU MAA pre-submission activities, Scientific Advice procedures, PIP, PRIME). Supported business development activities including proposal development and bid defense meetings. Show less

  • Director of Consulting

    Sept 2022 - May 2023

  • Director of Regulatory Strategy

    Feb 2014 - Sept 2022
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  Hope Tree School

  Sept 2023 - Dec 2023

  Student Support Assistant (Maths and Science)
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  Caring Together

  Dec 2023 - Nov 2024

  Member Board of Trustees

  Caring Together (www.caringtogether.org) is the leading charity providing support for unpaid family carers and those they care for across Cambridgeshire, Peterborough and Norfolk. It campaigns, provides information and advice, and runs services in local communities.

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  Wave Life Sciences

  Jan 2024 - now

  • Vice President, Regulatory and Policy

    Nov 2024 - now

  • Senior Director Regulatory Affairs

    Jan 2024 - Nov 2024