Consultant - Regulatory Affairs - Post Authorization Activities

5 days left

14 Apr 2021
14 May 2021
Clinical Research
Full Time
Contract Type
Experience Level
Experienced (non-manager)
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.

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