IQVIA

Reg Affairs Lead

5 days left

Company
IQVIA
Location
Warsaw
Posted
06 Feb 2021
Closes
07 Mar 2021
Ref
R1179775
Discipline
Regulatory Affairs
Hours
Full Time
Contract Type
Permanent
Experience Level
Experienced (non-manager)

To perform this job successfully, an individual must demonstrate project management skills and strong expertise.

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.

Qualifications: 

  • Degree in Lifescience
  • 2 or more years in a Project Management role leading similar sized efforts.
  •  4 or more years working in a Regulatory role assisting in the developing regulatory submission documents.
  • Experience in regulatory requirements for an asset transfer .
  • Direct experience with program management of regulatory affairs projects.
  • Effective communication skills.
  • Strong leadership skills.
  • Good decision maker. 

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.