Director Global Regulatory CMC Authoring

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.

Responsibilities:

• 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 j.pawl@proclinical.com.

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.

#Regulatory