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Senior Regulatory Affairs Associate, Strategic Compliance

Employer
Parexel
Location
Bucharest, Romania
Salary
Competitive
Start date
17 May 2019
Closing date
31 May 2019

View more

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

Job Details


PAREXEL values passion, global perspective and expertise and we are in the process of recruiting full time, permanent Seneior Associate Regulatory Affairs (Compliance focused) to join our PAREXEL Consulting team.

PAREXEL Consulting offers services which create and maximize product value for clients throughout the product lifecycle, leveraging our unique fusion of scientific, regulatory, and business expertise. We are the pre-eminent regulatory and GxP (Good Clinical, Laboratory, or Manufacturing Practice) compliance consulting practice in the world.

Main responsibilities include:

  • Gap analysis/maintenance of Pharma Quality Systems
  • SOP authoring and/or reviewing
  • Participation in client meetings

    Qualifications

  • Life science degree
  • Basic knowledge of key regulations, such as EudraLex Vol 4 and 21 CFR 210 & 211
  • Relevant Quality Assurance and Regulatory Compliance expertise
  • Experience working in a regulated laboratory or production preferred
  • Good project Management skills
  • Proactive approach and excellent communication skills
  • Fluent English
  • 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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