IQVIA

Regulatory Affairs Officer I

Company
IQVIA
Location
Reading
Salary
Competitive
Posted
08 Jan 2019
Closes
08 Feb 2019
Ref
R1058780
Discipline
Regulatory Affairs

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.

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