IQVIA

Reg Affairs Officer 2

Company
IQVIA
Location
Reading
Salary
-
Posted
16 Mar 2021
Closes
01 May 2021
Ref
R1188771
Discipline
Operations, Security
Hours
Full Time
Contract Type
Permanent
Experience Level
Experienced (non-manager)

Individual contributor who is fully proficient in applying subject matter knowledge for a professional discipline. Works under limited supervision.Essential Functions:

  • Acts as a Regulatory Specialist on more complex projects, which may include technical writing;
  • Prepares and/or reviews regulatory documentation in area of expertise, as appropriate;
  • Establishes relationships with many customers; may meet face to face without rest of the team to discuss regulatory issues, present lessons learned and discuss customer comments;
  • Acts as an SME/ expert in Regulatory knowledge in Chemistry, Manufacturing and Controls/ Lifecycle Maintenance/ Marketing Authorization Transfers/ Labeling/ Publishing as applicable;
  • Understands the Scope of Work, deliverables and management of budget for any given project and manages workload as appropriate;
  • May give guidance to junior colleagues, including feedback on the quality of technical documents, and may assist in their training and development;
  • May present to clients on complex regulatory processes at large full service bid defense meetings by phone or in person;
  • May act as reviewer for regulatory standard operating procedures, as assigned and appropriate;
  • May prepare and deliver regulatory training to IQVIA small groups or individuals;
  • Performs other tasks or assignments, as delegated by Regulatory management.

Technical Skills/Experience:

  • Degree in life science-related discipline or professional equivalent
  • Minimum of 3 years in regulatory CMC experience, focusing on marketed products
  • Experience of product development/manufacturing or analytical work is strongly preferred
  • Experience in regulatory procedures in Europe and/or emerging markets (e.g. variations/renewals/aggregate reports)
  • Experience in new MAA applications in Europe and/or emerging markets an advantage
  • Understanding of the content and typical level of detail in Module 3. 
  • Experience in conducting CMC Change Control Assessment – determine if regulatory action is required and if so determine the strategy, documentation requirements and timelines;
  • Provides regulatory strategy of CMC submissions worldwide
  • Preparation of technical justifications to support variations in collaboration with technical experts
  • Manage own work load, tracks project timelines, implements client requests and manages day-to-day workload.
  • Prepare and review Module 3 CTD sections for regulatory submissions (variations, renewals, responses to RA assessments);  
  • Experience in quality review of technical/ regulatory documents
  • Able to assist in review and revision of regulatory SOPs / act as reviewer as appropriate

Soft Skills

  • Excellent verbal and written communication skills in English are essential
  • Well organized
  • Be able to manage peaks of workload and prioritize workload with some supervision
  • Ability to work to tight timelines
  • Open and communicative personality
  • Good team player
  • Good negotiating skills
  •  Ability to identify issues and contribute to their resolution
  • Strong computer skills, including MS Office applications, data and document management systems
  • Adaptable to change
  • Cultural awareness

LI-MS

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.

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