IQVIA

Regulatory Affairs Officer 1

Company
IQVIA
Location
Reading
Posted
04 Feb 2021
Closes
06 Mar 2021
Ref
R1182650
Discipline
Regulatory Affairs
Hours
Full Time
Contract Type
Permanent
Experience Level
Entry level
Regulatory Affairs Specialist supports with Lifecycle maintenance and Marketing Authorisation Transfers. Provides operational support to ensure the wellbeing of clinical research subjects and the best possible project outcomes.

Essential Functions:

  • Prepares and reviews regulatory submissions on behalf of clinical research studies and secures marketing authorizations.
  • Technical writing to complete regulatory and/or technical documents to ensure complete and high-quality regulatory deliverables;
  • Communicates regulatory issues and opportunities to customers;
  • Provides strategic regulatory guidance to project teams.
Requirements:
  • Degree in Lifescience or related discipline.
  • At least  2 years relevant experience.
  • Good understanding of the Research and Development process (Chemistry, Manufacturing & Controls, Preclinical and Clinical), laws and related guidelines, as appropriate.
  • Ability to establish and maintain effective working relationships with coworkers, managers and clients.
  • Ability to work on several projects, with direction from senior staff as appropriate.

LI-MS8

At IQVIA, we believe in pushing the boundaries of human science and data science to make the biggest impact possible – to help our customers create a healthier world. The advanced analytics, technology solutions and contract research services we provide to the life sciences industry are made possible by our 67,000+ employees around the world who apply their insight, curiosity and intellectual courage every step of the way. Learn more at jobs.iqvia.com.

Similar jobs

Similar jobs