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Regulatory Affairs Officer I (R1058780) in Reading, UK at IQVIA™

Date Posted: 2/4/2019

Job Snapshot

  • Employee Type:
    Full-Time
  • Location:
    Reading, UK
  • Experience:
    Not Specified
  • Date Posted:
    2/4/2019
  • Job ID:
    R1058780

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

Prepares and/or reviews regulatory submissions to support clinical trial and marketing authorisation activities for either internal and/or external clients.  Provides regulatory support for assigned projects.



RESPONSIBILITIES

  • Acts as a Regulatory Team member involved in projects, under the guidance of senior staff.
  • Manages day-to-day workload in collaboration with senior staff, as appropriate.
  • Prepares and/or reviews regulatory documentation in area of expertise, as appropriate.
  • Actively participates with internal and external customers and communicates confidently in straightforward matters.
  • Understands the Scope of Work, and deliverables for a given project.
  • May prepare slides and background material for meetings under senior guidance and present to clients by phone or in person.


REQUIRED KNOWLEDGE, SKILLS AND ABILITIES

Technical Skills/Experience

  • Preparation of relevant CTD (Common Technical Dossier) documents to support submissions (mainly Module 1), in collaboration with Technical/CMC/Labelling experts
  • Quality review of technical/ regulatory documents
  • Interaction with Regulatory Agencies (EU and/or National Agency)
  • Regulatory strategy and determination of documentation requirements, timelines, budgets
  • Revision/review of regulatory SOPs, as appropriate
  • Project management experience -  an advantage

Soft Skills

  • Ability to work to tight timelines and manage peaks in workload
  • Good team player
  • Good negotiating skills and the ability to identify and resolve issues
  • Excellent verbal and written communication skills
  • Excellent computer skills e.g. Word, Excel, data and document management systems
  • Cultural awareness for global ways of working
  • Able to act as a mentor to junior colleagues and to assist in their training and development as appropriate

Key words phrases are: 

Post Approval; Variation; Renewal; Referral; change control assessment; regulatory strategy; team work.



MINIMUM REQUIRED EDUCATION AND EXPERIENCE

•      Degree in life science-related discipline or professional equivalent plus at least 2 year’s relevant experience*   

        (*or combination of education, training and experience)

2 years regulatory experience, focusing on lifecycle maintenance of marketed products in Europe and/or emerging markets (e.g. variations, renewals, new Marketing Authorisation Applications (MAAs) submissions.

Please note this role is office based in Reading

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: R1058780