IQVIA

Regulatory Affairs Officer 2

Company
IQVIA
Location
Reading
Posted
30 Apr 2021
Closes
30 May 2021
Ref
R1205630
Discipline
Regulatory Affairs
Hours
Full Time
Contract Type
Permanent
Experience Level
Experienced (non-manager)
Essential functions:
  • Perform the regulatory affairs activities for individual country license transfer, withdrawal, variation etc.
  • Execute preparation of assigned territory packages in accordance with the MA transfer strategy and report on progress with inputs from the appropriate asset transfer representative (Sponsor, Partner or Supplier) collaborating on assigned territory package;
  • Establishes relationships with many customers; may meet face to face without rest of the team to discuss regulatory issues, present lessons learned and discuss customer comments;
  • Verify regulatory intelligence assumptions and provide opinions on strategy and requirements to successfully complete MAH transfer, withdrawal, variations etc;
  • Additionally, Lead and manage the license transfer readiness process for asset transfer (divestment/acquisition/withdrawal/variation etc);
  • Understands the Scope of Work, deliverables and management of budget for any given project and manages workload as appropriate;
  • May give guidance to junior colleagues, including feedback on the quality of technical documents, and may assist in their training and development;
  • May present to clients on complex regulatory processes at large full service bid defense meetings by phone or in person;
  • May act as reviewer for regulatory standard operating procedures, as assigned and appropriate;
  • May prepare and deliver regulatory training to IQVIA small groups or individuals;
  • Performs other tasks or assignments, as delegated by Regulatory management
Requirements:
  • 3-5 years relevant regulatory experience, including license maintenance across a range of markets, including regulated markets
  • Thorough knowledge of the product maintenance process
  • Previous CRO experience is advantageous but not mandatory
  • Experience working on asset transfer projects in terms of regulatory activities is preferred
  • University Degree in Science or related discipline
  • Strong communication and leadership skills

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 70,000+ 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