Associate Director, Global Regulatory Affairs - based in EMEA region - (R1024897) in Reading, UK at IQVIA™

Date Posted: 5/9/2018

Job Snapshot

  • Employee Type:
    Full-Time
  • Location:
    Reading, UK
  • Experience:
    At least 8 year(s)
  • Date Posted:
    5/9/2018
  • Job ID:
    R1024897

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.

PURPOSE

Direct, oversee and manage complex regulatory projects, ensuring quality deliverables on time and within budget. Ensure that all project work is completed in accordance with SOPs, policies and practices.

RESPONSIBILITIESMay act as a Project Manager for a large stand-alone programme, involving several regulatory or technical deliverablesand/or region, and/or operation. Undertakes risk analysis, management and contingency plans, as appropriate.

•Provides strategic regulatory and/or technical consultancy on a variety of projects, internally and externally, usinginnovative 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.

•May support global regulatory or technical initiatives or act as a regional representative on a cross-functional initiative.

•Performs other tasks or assignments, as delegated by Regulatory management.

All responsibilities are essential job functions unless noted as nonessential (N).



Job Requirements

REQUIRED KNOWLEDGE, SKILLS AND ABILITIES

  • Extensive experience in regulatory and/or technical writing
  • 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
  • Ability to exercise independent judgement taking calculated risks when making decisions

MINIMUM REQUIRED EDUCATION AND EXPERIENCE Degree in life science-related discipline or professional equivalent plus at least 8 years relevant experience* including6 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

 
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: R1024897