IQVIA

Reg Affairs Officer 1

Company
IQVIA
Location
Reading
Salary
Negotiable
Posted
12 Sep 2018
Closes
15 Dec 2018
Ref
1808454
Discipline
R & D , Scientific
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

 

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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