Director Global Regulatory CMC Authoring

Highly Competitive
  1. Permanent
  2. CMC
  3. Germany
Mainz, Germany
Posting date: 13 Mar 2024

Proclinical are recruiting for a Director Global Regulatory CMC Authoring to join a biotech organisation. This role is on a permanent basis and is located in Mainz.

Please ensure that you are eligible for working in the location without any sponsorship or relocation assistance.


  • Write international quality regulatory documentation for various medium-complexity projects in a timely manner and rendering to pertinent processes.
  • Outline and form platform approaches to the preparation of quality regulatory documentation.
  • Assist alignment of structure and contents of quality regulatory documentation across company platforms.
  • Partake in the development of regulatory CMC method for designated projects.
  • Mediate with pertinent shareholders to enable the preparation of quality regulatory documentation.
  • Other duties may be assigned.

Key Skills and Requirements:

  • Familiarity in writing regulatory CMC documents for clinical trial applications and/or marketing authorisations.
  • Expertise on product life cycle management and 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 discipline.
  • Demonstrable experience within international regulatory affairs CMC focusing on Biologics, Vaccines.
  • Communication skills both verbally and in writing.
  • An organised individual with the ability to think analytically and create ideas.

If you are having difficulty in applying or if you have any questions, please contact Jaeme Pawl at

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

Proclinical Staffing is an equal opportunity employer.