IQVIA

Regulatory Affairs Manager

Company
IQVIA
Location
Reading
Posted
19 Feb 2021
Closes
20 Mar 2021
Ref
R1184628
Discipline
Regulatory Affairs
Hours
Full Time
Contract Type
Permanent
Experience Level
Experienced (non-manager)

Responsibilities:

  • May act as a Project Manager for stand-alone projects, involving several regulatory or technical deliverables and/or region, and/or operation
  • Provides strategic regulatory and/or technical consultancy on a variety of projects, internally and externally, using innovative solutions where appropriate
  • May manage meetings with Regulatory Agencies
  • May write and/or review a complete single service regulatory proposal and defend costs and timelines to clients
  • Provides mentorship to junior colleagues and advise others on many regulatory document types
  • May plan and deliver workshops or presentations on Regulatory Affairs topics for conferences or publications
  • May be assigned as Reviewer and/or Approver for Regulatory SOPs or cross-functional SOPs owned by other operations
  • Performs other tasks or assignments, as delegated by Regulatory management

Requirements:

  • Extensive experience in regulatory and/or technical writing
  • CMC writing experience and or clinical writing experience
  • Advanced negotiating and influencing skills and the ability to identify and resolve issues, using flexible adaptable approach
  • Remains calm, assertive and diplomatic in challenging interactions with customers
  • Strong software and computer skills, including MS Office applications
  • Acts as a role model to junior colleagues; possesses a positive attitude and communication style to customers and colleagues. Communicates effectively with all levels of the organization and remains motivated and enthusiastic in times of change and other pressure situations

Minimum required education and experience:

  • Degree in life science-related discipline or professional equivalent plus at least 8 years relevant experience* including 6 years regulatory experience (*or combination of education, training and experience)

Physical requirements:

  • Extensive use of telephone and face-to-face communication requiring accurate perception of speech
  • Extensive use of keyboard requiring repetitive motion of fingers
  • Regular sitting for extended periods of time
  • Travel will be required

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.