This site uses cookies. To find out more, see our Cookies Policy

Regulatory Affairs Officer II CMC (R1062340) in Reading, UK at IQVIA™

Date Posted: 3/28/2019

Job Snapshot

  • Employee Type:
    Full-Time
  • Location:
    Reading, UK
  • Experience:
    Not Specified
  • Date Posted:
    3/28/2019
  • Job ID:
    R1062340

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.

RESPONSIBILITIES:

Acts as CMC lead/specialist for client projects, will have CMC responsibility for a portfolio of products. 

  • Conducts CMC change control assessments
  • Provides regulatory strategy of CMC submissions worldwide
  • Authors and reviews Module 3 sections
  • Prepares and reviews CMC documentation required to support submissions e.g. IMPD updates, MAA, post approval variations and renewals. 
  • Manage own work load, tracks project timelines, implements client requests and manages day-to-day workload.
  • Actively participates in project teams with internal and external customers independently and communicates confidently in straightforward matters
  • May prepare and deliver training, as appropriate.
  • Performs other tasks or assignments, as delegated by Regulatory management.
  • Acts as mentor to junior colleagues
  • May act as Project Manager/CMC RA Lead on projects

REQUIRED KNOWLEDGE, SKILLS AND ABILITIES:

Technical Skills

  • Bachelor of Science Degree in life science related discipline
  • Minimum 2 years regulatory CMC experience, focusing on marketed products in Europe and/or emerging markets
  • Knowledge of variations/renewals/procedures in Europe and/or emerging markets
  • Complete understanding of the content and typical level of detail in Module 3. 
  • Conducted CMC Change Control Assessment – determine if regulatory action is required and if so determine the strategy, documentation requirements and timelines;
  • Preparation of technical justifications to support variations – prepared in collaboration with technical experts
  • Manage cross functional interactions to support CMC activities;
  • Prepare and review Module 3 CTD sections for regulatory submissions (variations, renewals, responses to RA assessments);  
  • Project Management of small to medium size projects
  • Experience of product development/manufacturing or analytical work is strongly preferred

Soft Skills

  • Be able to manage own workload
  • Ability to work to tight timelines
  • Adaptable to change
  • Excellent verbal and written communication skills
  • Excellent computer skills e.g. Word, Excel
  • Experience of using document management and change control systems
  • Good team player
  • Cultural awareness
  • Project management 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: R1062340