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16611-Sr Dir, Reg Affairs (R1024521) in Reading, UK at IQVIA™

Date Posted: 11/28/2018

Job Snapshot

  • Employee Type:
  • Location:
    Reading, UK
  • Experience:
    Not Specified
  • Date Posted:
  • Job ID:

Job Description

Join us on our exciting journey! IQVIA™ is The Human Data Science Company™, focused on using data and science to help healthcare clients find better solutions for their patients. Formed through the merger of IMS Health and Quintiles, IQVIA offers a broad range of solutions that harness advances in healthcare information, technology, analytics and human ingenuity to drive healthcare forward.

 Provide STRATEGIC REGULATORY support for client projects involving development of Target Product Profiles, Clinical Development Plans, and Study Designs.  Provide STRATEGIC REGULATORY support for Due Diligence Product Evaluations and interactions with regulatory authorities.  


Using broad management discretion, direct, oversee and manage complex, regulatory project(s), ensuring quality deliverables on time and within budget. Ensure that all work is completed in accordance with SOPs, policies and practices.


_ May act as a global contact and/or lead for a specific customer.

_ May take a proactive role in developing long standing relationships with preferred IQVIA customers, and may take a leadership role in bid defence strategy and planning, as appropriate.

_ Ensures compliance of RA processes and prepares for full RA Systems Audits; accountable for any subsequent action plans.

_ Continually looks for process improvements.

_ Competently manages meetings/expectations with Regulatory Agencies and/or groups within IQVIA.

_ May lead major, global cross-functional initiatives, accountable for success.

_ May represent IQVIA by leading a cross-industry workgroup in an area of expertise.


_ Extensive experience in regulatory and/or technical writing and/or process management

_ Ability to make difficult judgment calls within sphere of responsibility. Demonstrates advanced negotiating, influencing and motivating skills, with the ability to identify and resolve issues at a senior level within IQVIA and customer organizations

_ Strong software and computer skills, including MS Office applications

_ Acts as a role model for professionalism and a respected ambassador for the Regulatory Business Unit, remaining effective in difficult, stressful and/or highly sensitive situations

_ Ability to accept senior management decisions and deliver positive messages to peers

_ Ability to communicate effectively at all levels in the organization, consistently demonstrating confidence and authority within remit

_ Ability to monitor the market and demonstrate knowledge of competitors and clients


• Degree in life science-related discipline or professional equivalent* plus at least 12 years regulatory experience (*or combination of education, training and experience)

We know that meaningful results require not only the right approach but also the right people. Regardless of your role, we invite you to reimagine healthcare with us. You will have the opportunity to play an important part in helping our clients drive healthcare forward and ultimately improve human health outcomes. Whatever your career goals, we are here to ensure you get there! We invite you to join IQVIA™

Job ID: R1024521