Director of Global Regulatory Affairs - Mainz, Deutschland - Hobson Prior

Hobson Prior
Hobson Prior
Geprüftes Unternehmen
Mainz, Deutschland

vor 1 Woche

Lena Wagner

Geschrieben von:

Lena Wagner

beBee Recruiter
Beschreibung

Salary:

€ €130000 per annum
Job type:

Permanent


Location:

Mainz, Germany


Function:

Regulatory Affairs, CMC


Posted:14/03/2024


Ref:

BBBH2487- Hi I'm
Henry
, I manage this role


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 mediumcomplexity 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 postapproval 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.

Requirements:


  • 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.


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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