Nina Arden Email & Phone Number

Excited to venture into a my career path into regulatory affairs in Clinical Research

Listed skills include Leadership, Administrative Assistance, R, Public Speaking, and 34 others.

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  Regulatory Submission Coordinator

  Medpace

  Aug 2022 - Present

  • Hands-on experience preparing, reviewing, and submitting regulatory documentation• Creating guidance for the team to utilise when making submissions• Presenting queries or concerns faced during start up processes or submission with solutions • Collecting reviewing and compiling documents for site start ups • Preparing, reviewing, and filing clinical trial applications for UK & Ireland• Providing input on regulatory submissions documents and timelines• Ensuring… Show more • Hands-on experience preparing, reviewing, and submitting regulatory documentation• Creating guidance for the team to utilise when making submissions• Presenting queries or concerns faced during start up processes or submission with solutions • Collecting reviewing and compiling documents for site start ups • Preparing, reviewing, and filing clinical trial applications for UK & Ireland• Providing input on regulatory submissions documents and timelines• Ensuring submissions comply with applicable regulations and guidance documents• Advising on changing country regulations and compliance requirements• Track submissions and ensure timely filing of documents on various TMF platforms Show less