Regulatory Affairs Manager Freelance

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  • September 2021
  • März 2022
  • Nordrhein-Westfalen
  • auf Anfrage
  • Remote
  • 16.09.2021
  • 33760719_1631720020

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Projektbeschreibung

*** Regulatory Affairs Manager - Freelance ***

As a Recruiter for the Life Sciences field, I wanted share with you my Regulatory Affairs Manager - FREELANCE function for one of my clients in Germany.

Start ASAP, full or part-time & on a 100% remote basis.

Interested? If so, take a glance at the details below and gladly get in touch at your earliest convenience by email for more information.

Main tasks:

* External support with EU and US approval applications with a focus on CMC
* Creation and testing as well as adjustments of IMPD's
* Preparation and approval of clinical trial applications in Germany, the Netherlands and France
* Answers to health questions from the relevant authorities

Expected skills:

* IMPD experience
* ATMP experience (of advantage)
* Solid kknowledge of module 3 of the eCTD
* Degree in pharmacy, biology, chemistry or a similar subject
* 5 years of experience in regulatory affairs, product development and approval management with a focus on biologics
* Organizational and communication skills in English (oral and written)
* Hands-on mentality

Start: ASAP in full OR part-time capacity
Region: Germany (collaboration is 100% REMOTE)
Duration: 6 month contract (with possibility of extension) over freelance

I look forward to your input and a possible mutual collaboration in the near future.

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