Director of Global Regulatory Affairs - CMC Authoring

€120000 - €130000 per annum
  1. Permanent
Mainz, Germany
  1. Regulatory Affairs, CMC
Posted: 14/03/2024

This vacancy has now expired. Please see similar roles below...

Hobson Prior are partnering with a brilliant biotech organisation who are currently looking for an individual to join their team on a permanent basis. The opening position that is available at the company is for a Director of Global Regulatory Affairs - CMC Authoring. For more information, please get in touch now!

Please note that to be considered for this role you must have the right to work in this location.

Key Responsibilities:

  • For this role, you will write international quality regulatory documentation for various medium-complexity project(s) rendering to the pertinent processes in a timely manner.
  • Outline and form platform approaches to prepare quality regulatory documentation use in development, registration and post-approval stages.
  • Assist with the alignment of structure and content of quality regulatory documentation across company platforms.
  • Participate in the development of regulatory CMC method for the allocated project(s).
  • Mediate with pertinent shareholders to enable the preparation of quality regulatory documentation of the highest quality and strive to optimise/simplify the writing procedures and shorten the writing times.
  • Any other assigned duties.


  • Familiarity in writing regulatory CMC documents for clinical trial applications such as quality parts of INDs/MPD, and/or marketing authorisations such as quality part of variations, BLAs, MMAs, etc.
  • Expertise on product life cycle management as well as comprehension of scientific principles and regulatory CMC needs pertinent to international drug development.
  • Educated to a degree level in a biochemistry, biology, chemistry, pharmacy or similar.
  • Demonstrable experience in international regulatory affairs CMC, focusing on Biologics and Vaccines.

Apply now:

If you are interested in learning more or applying to this exciting opportunity then please click "Apply" and upload a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist directly, please select "Contact me" at the top of this page.

Hobson Prior is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Hobson Prior is acting as an Employment Agency in relation to this vacancy.

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