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Regulatory Affairs Consultant - Post Authorization Activities

Employer
Parexel
Location
Switzerland
Salary
Competitive
Start date
10 Sep 2021
Closing date
6 Oct 2021

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

Job Details

Job Description

We are recruiting for a Consultant, Regulatory Affairs withRegulatory Affairs experience in the Switzerland regulatory lifecycle maintenance submissions (variations, renewals...) and post authorization activities.

You will be responsible for:
  • Provision of strategic advice regarding local regulatory requirements to an internal or external stakeholders
  • Impact Assessment of CMC and labelling Change Controls and/or CCDS
  • Module 1 documents preparation
  • Review of labelling and Artwork in the Country official languages: German, French, Italian
  • Core packages adaptation to local requirements
  • Update of section 1 (country specific) for PBRERs
  • Review of final published submission package
  • Package Submission to Health Authority (includes Requests for Information)
  • Updates to local compendia/HA websites
  • Liaison with Local Country Offices (client)
  • Liaison with internal Global Regulatory Affairs team
  • Liaison with Health Authority
  • Translation ≤1000 words (cover letter/application form/letter from Health Authority...)
  • Qualifications

    Experience and Qualifications Required:
    - Several years of experience working for a CRO, within regulatory lifecycle maintenance and post authorisation activities
    - Bachelor's Degree in a Scientific or Technical Discipline, Advanced Degree Preferred
    - Fluent business English
    - Desirable: Additional language skills: German, Italian, French (at least 2)Why Work at Parexel

    There are pivotal moments in every career: Sharing new treatments. Improving processes. Delivering life-saving advances. The people who succeed are the ones who make the journey go further and faster every time. What if you had a partner to support you as you reach the next level in your professional path? A partner who believes a collaborative environment is key to achieving your goals? A partner who is dedicated to your health and wellness so you can help make a difference in the lives of millions worldwide?

    That's Parexel. We're a diverse team of professionals focused on one goal: getting treatments into the hands of those who need them most. Working together, the results we bring to our clients and the opportunities we bring to our team get better with every step.

    How can we help you on your journey? Find your path, and learn more on LinkedIn, YouTube, Facebook, Twitter, and Glassdoor.

    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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