Regulatory Consultant - Non Clinical

A top 10 pharmaceutical company is looking to hire a Regulatory Consultant (Non-Clinical) to join their team in Ware, UK. This is a contract position.

Job Responsibilities:

This role will assist in the preparation of nonclinical regulatory dossiers including:

• Global CTD dossiers for Established Products
• Clinical Trial Applications

This role involves the continued preservation and update of nonclinical components of established product dossiers by:

• Completion of periodic updates of the documents to ensure that they reflect a contemporary understanding of each product.
• Compilation of specific CTD components from existing submission documentation.
• Comprehensive literature/information searches both externally and internally (specified company databases).
• Generation of nonclinical submission components to support established pharmaceutical products eg Label unification, ad hoc requests for information.
• Collaboration with nonclinical development and regulatory groups.

The timely and accurate delivery of regulatory dossiers for the approval and maintenance of product marketing and clinical trials applications

• Authoring and coordinating the nonclinical components of regulatory documents such as Investigator brochures updates.
• Facilitating construction of nonclinical documentation to support applications in China.
• Responding to requests for nonclinical documentation in a timely manner.
• Coordinating and preparing the nonclinical components of lifecycle documents.
• Coordination with other disciplines eg Nonclinical development and CMC.
• Preparation/review of tabular data summaries and study listings tables for ongoing submission support.

Required Qualifications:

• Minimum graduate level, with a relevant biologically based scientific background.
• Understanding of pharmacology, pharmacokinetics & toxicology related to drug development
• Excellent written and verbal communication skills, computer literate and competent in the use of Microsoft Word.
• Proficiency in searching on-line scientific publication databases.

To Apply:

Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.

In case you have difficulty in applying or if you have any questions, please contact Peter Duvall at p.duvall@Proclinical.com or upload your CV on our website - www.Proclinical.com.

A full job description is available on request.

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