Experienced Regulatory professional providing regulatory guidance and support on a variety of project teams, for both developmental and marketed products, in a variety of therapy areas. Liaising with matrix teams to ensure plans will deliver desired goals. Practical experience of the preparation, co-ordination and submission of a variety of regulatory documents (eg variations, renewals, CTAs, briefing documents, presentations to regulatory agencies). Liason activities with Regulatory Agencies.Specialties: Regulatory guidance and operational management in all phases of product development and regulatory submissions.
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Currently On Career BreakN/A Apr 2016 - Present
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Regulatory And Study Start-Up ManagerQuintiles Jan 2014 - Apr 2016Livingston, Scotland -
Regulatory Affairs Specialist (Part-Time)Johnson & Johnson Medical Ltd Jun 2010 - Dec 2013- Co-ordination of regulatory requests and submissions to register, update & renew approvals for medical devices in International markets - Advising project teams on International registration requirement for Regulatory Strategies for new product launches and changes - Liaising with Quality Assurance and Manufacturing to ensure compliant regulatory approvals -
Independent Regulatory Consultant (Part-Time)Regwise May 2010 - Aug 2011- Regulatory guidance through all phases of product development and licence maintenance. - Preparation, submission and maintenance of high quality regulatory submissions including clinical trial applications, paediatric investigation plans, requests for scientific advice/protocol assistance, marketing authorisation applications including Type I & Type II variations and renewals.
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Senior ConsultantThe Weinberg Group Apr 2009 - Jan 2010* Regulatory support and advice in all phases of product development.* Preparation and management of clinical trial application to Regulatory Authorities.* Planning, compilation and submission of marketing authorisation application dossiers*Maintenance of marketing authorisation including variations, renewals, PSURs etc -
Regulatory Project ManagerGlaxosmithkline Oct 2004 - Apr 2009* Regulatory guidance and support on a variety of project teams, for both developmental and marketed products. * Maintainance of a marketing authorisation via the Centralised Procedure including clinical and pharmaceutical variations, PSURs and renewal applications.* Practical experiences of the regulatory requirements for clinical trial applications, their maintenance via amendments and end of trial commitments.* Experience of planning, co-ordinating and /or preparation, review and submission of a variety of Common Technical Documents. Experience of eCTD. -
Principal Research ScientistGlaxosmithkline Dec 1993 - Oct 2004* Variety of gene expression and protein biochemistry techniques* Assay Development for 7TM receptors.* In addition to a laboratory bench role I was a project manager leading a drug discovery program in the Target-to-Lead phase. Involved close working in a group of multi-disciplinary scientists in the UK and US.
Elaine Wise Education Details
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Science Communication -
University Of DundeeBiochemistry
Frequently Asked Questions about Elaine Wise
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Elaine Wise's current role is Currently on career break at N/a.
What schools did Elaine Wise attend?
Elaine Wise attended Birkbeck, University Of London, University Of Dundee.
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