Regulatory Affairs Assistant

3 weeks ago


Cambridge, Cambridgeshire, United Kingdom i-Pharm Consulting Full time

Job Title: Regulatory Affairs Assistant

Contract Duration: 12 Months

Location: United Kingdom, Cambridge

Key Responsibilities:

  • Perform data entry using Gilead RIM System to enter relevant information to support key CMC RA stakeholders.
  • Work collaboratively to support the team by executing routine data entry, such as the input of submission related dates, regulatory assessment comments.
  • Ensure completeness, correctness and consistency of data.
  • Responsible for acquisition of required system skills and knowledge; training supported by manager and peers.
  • Work is performed under the general supervision of more senior Regulatory Affairs CMC professionals.

Requirements:

  • Should have familiarity with data entry into complex information systems.
  • Should have experience with Veeva Vaults, experience with the RIM Vault preferred.
  • Strong verbal and written communication skills and interpersonal skills.
  • Excellent organizational skills and ability to work on multiple concurrent projects with tight timelines are required.
  • Basic understanding of role of Regulatory Affairs and regulatory requirements in a limited number of areas is required.
  • Scientific background preferred.
  • Biologics experience is a plus.

To apply or find out more, please contact Sharleney Chandraratna at schandraratna@i-pharmconsulting.com or call +44 (0) 2075510732.



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