Regulatory Affairs Associate II

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Job TitleRegulatory Affairs Associate II
Job TypePermanent
Job Scope
Business AreaGlobal Regulatory Affairs
LocationUK South East
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The Regulatory Affairs Associate II provides regulatory support and expertise on assigned programmes, and is responsible for specific pieces of moderately complex projects. In addition, the Regulatory Affairs Associate II reviews scientific documents intended for submission to regulatory authorities. This is a fantastic opportunity to work with cutting edge science and an organisation that is committed to your career development.

Key responsibilities

  • Assists with the planning and preparation of submissions to regulatory authorities, with minimal supervision
  • Independently solves problems of moderate complexity and scope, with limited supervision
  • Determines the best and most appropriate methods and procedures on new assignments independently
  • Applies knowledge of regulatory requirements to the review of scientific documentation intended for submission to regulatory authorities
  • Analyses new regulations and guidelines and makes process improvement recommendations to group
  • Prepares and delivers effective presentations for department meetings
  • May represent Regulatory Affairs department on assigned project sub-teams and/or task forces, with supervision
  • May conduct training, with supervision
  • Performs other duties as assigned

Minimum Qualifications

  • Experience in preparation and/or submission of documentation for European agencies: such as CTAs, PIPs, variations PSURs.
  • Demonstrates effective, self-sufficient communication skills, especially in peer-directed presentations
  • Displays sound project management skills
  • Exercises good judgment within defined procedures and practices to determine viable solutions
  • Displays good interpersonal skills and ability to deal effectively with a variety of personnel
  • Demonstrates advanced knowledge and understanding of applicable regulations
  • Fluent written and spoken English and second European language an asset

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