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Regulatory Affairs Associate (Regulatory Publishing)

Employer
Parexel
Location
Bucharest, Romania
Salary
Competitive
Start date
16 Feb 2019
Closing date
18 Mar 2019

View more

Discipline
Clinical Research
Hours
Full Time
Contract Type
Permanent
Experience Level
Experienced (non-manager)

Job Details


Main accountabilities:

  • Responsible for the publishing, and quality control of Regulatory submissions (eCTD core package creation; eCTD baseline; eCTD lifecycle maintenance)
  • Performs word formatting and familiar with MS Word plugins
  • Produces high-quality submission by publishing, quality review and delivery of submissions in paper, NeeS and electronic format. For paper submissions, creates cross-references, table of content, tab / slip-sheets, and volumes. For electronic submissions, performs bookmarking, hyper-linking, and tables of content creation according to Health Authority (HA) guidelines.
  • Publishes Regulatory documents using Publishing software applications in the client specified environment according to internal processes and agreed-upon timeline.
  • Performs quality control of published submissions before release to the HAs and/or clients. This may involve detailed verification of paper and / or electronic components to ensure compliance with HA regulations.
  • Takes accountability with different Regulatory submission contact points to ensure proper organization of a timely submission.
  • Support key processes are in place and functioning efficiently to facilitate teamwork and local communication.
  • Proactively trouble-shoots technical/quality issues relating to the preparation and dispatch of submissions.
  • 'Can do' attitude and a practical approach to problem solving.
    Qualifications
    Key requirements:

  • Pharmacy or Life Sciences with or without postgraduate qualifications
  • Knowledge in ICH guidelines, Regulatory Documentation & Regulatory Submissions with experience in eCTD Publishing
  • Proficiency in using PDF Plugins, MS Office and Regulatory Publishing tool
  • Ability to work within a team, communicate effectively across all levels and excellent organizational skills
  • Good project Management skills
  • Fluent English and Romanian

    Key requirements:

  • Pharmacy or Life Sciences with or without postgraduate qualifications
  • Knowledge in ICH guidelines, Regulatory Documentation & Regulatory Submissions with experience in eCTD Publishing
  • Proficiency in using PDF Plugins, MS Office and Regulatory Publishing tool
  • Ability to work within a team, communicate effectively across all levels and excellent organizational skills
  • Good project Management skills
  • Fluent English and Romanian
  • Company

    parexel

    When you join us, you’re joining a team that sees everything they do as an opportunity to transform the world for patients everywhere. When our employees bring their many perspectives together to tackle a new challenge, there’s no limit to what they can accomplish. Through it all, at the center of all we do, is a patient whose life could change – forever. And together, we’ll do it With Heart™.

    How to describe Parexel’s culture in one word: 

    Henry

     

     

    Working With Heart™ - Christina's perspective:

    Working With Heart™ - Christina's perspective:

     

    Careers Blog | Our Culture | Diversity, Equity & Inclusion | Benefits | Our Hiring Process

    Parexel is among the world’s largest clinical research organizations (CROs), providing the full range of Phase I to IV clinical development services to help lifesaving treatments reach patients faster. Leveraging the breadth of our clinical, regulatory, and therapeutic expertise, our team of more than 21,000 global professionals works in partnership with biopharmaceutical leaders, emerging innovators, and sites to design and deliver clinical trials with patients in mind, increasing access and participation to make clinical research a care option for anyone, anywhere. 

    Company info
    Website
    Telephone
    +44 1895 238000
    Location
    The Quays
    101-105 Oxford Road
    Uxbridge
    Middx
    UB8 1LZ
    United Kingdom

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