Regulatory Affairs Coordinator

Job Ref: J32087
Sector: Clinical
Sub-sector: Pharmaceuticals
Job Type: Temporary
Date Added: 28 May 2019
  • Berkshire, England, UK Berkshire Berkshire UK SL6 4UB
  • Competitive
    HOUR
  • Natasha Rollason
SRG https://www.srg.co.uk https://www.srg.co.uk/-/media/srg/logos/srg_web_2018.png

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SRG are recruiting on behalf of a Global Pharmaceutical Company who have opened a new vacancy within their Regulatory team and are looking to recruit a Regulatory Affairs Coordinator - on an initial 12 Month contract to be based at their offices in Berkshire.

Key Responsibilities:

  • Operational support to Clinical Trial Submissions team, leads for submission preparation and processing of initial CTA applications, amendments, end of trial notifications etc.
  • Preparation of documentation associated with new initial CTAs and CTA maintenance activities such as substantial amendments, end of trial notifications etc.
  • Review of and input on documents related to clinical trial submissions managed by other stakeholders such as IB and Protocols.
  • Ensure approved company CTA processes are followed.
  • Ensure all relevant databases, activity trackers and questions database are populated within agreed timelines and compliance/reporting requirements met, and provide operational support for Regulatory and/or non-Regulatory systems that are critical for Regulatory submission and maintenance activities.
  • Provide technical support on document preparation e.g. Excel spreadsheets, Power point presentations.
  • Organizing legalization and signature of documents in line with global affiliate requirements.
  • Undertake all necessary training in order to achieve compliance with internal/external processes.
  • Provide operational/administrative support for the Clinical Trials Regulatory Group.
  • Support SOP reviews and updates when required.
  • Comply with the company's policies and procedures to meet statutory, quality and business requirements within the overall strategy and objectives of the company.

Skills/Experience Required:

Education:

  • Life Sciences Degree qualified.

Skills:

  • 1 year Regulatory Affairs or R&D experience preferable.
  • Good Information Technology skills, proven ability to utilise a variety of computer application packages, such as MS Word, Excel, PowerPoint, Adobe Acrobat and global databases.
  • Proactive verbal and written communication style at all levels.
  • Shows high level of initiative and ability to work independently
  • Has excellent communication/presentation skills, written and verbal; fluency in English.
  • Strong proven personal development and motivational skills.
  • Strong interpersonal, organisational and team working skills.

If you are interested in this role or would like to have a confidential career discussion regarding other Regulatory Opportunities. Please contact me: Natasha.Rollason@srg.co.uk or +441753 589673

SRG
27/06/2019 15:52:08
GBP