Regulatory Senior Executive 74151

Job Ref: J27766
Sector: Clinical
Sub-sector: Pharmaceuticals
Job Type: Temporary
Date Added: 03 October 2018
  • Middlesex, England, UK
  • 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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The Role

To prepare high quality CMC detailed regulatory documents using varied information sources. liaising closely with other company personnel to ensure accuracy of such records.

Role Requirements

  • Work to agreed deadlines and maintaining records to reflecting project status.
  • Hands on technical experience in authoring CMC dossiers
  • Taking on the project lead, manufacturing changes and post approval
  • Responsible for highlighting potential delaying factors promptly to line management and sharing knowledge of regulatory documentation and procedures with others to assist in problem solving.
  • Proactively pursue process improvement and sharing of best practice.
  • Required Skills CMC experience :good written and oral communication and networking skills. Demonstrate ability to focus and work with attention to detail.
  • Demonstrate ability to retain critical information. Be aware of the contents of a marketing authorization application.
  • Demonstrate team working and effective time management skills.
  • Be a dynamic and highly motivated individual
  • Be proficient in the use of IT packages such as Word and excel.
  • Demonstrate problem solving skills

Education

Minimum degree level, in any life sciences.

Working experience within Regulatory Affairs/CMC.

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

The recruiter has stated that all applicants for this job should be able to prove they are legally entitled to work in the EU/UK. SRG is a trading name of Science Recruitment Group Ltd an Employment Business/Agency.

SRG
02/11/2018 10:18:32
GBP .