Regulatory Affairs Associate

SRG Clinical
01 Oct 2017
02 Nov 2017
Contract Type
Full Time
My Client a Global Pharmaceutical Company has opened a new vacancy within their Regulatory team and is looking to recruit a Regulatory Affairs Associate on an initial 12 month contract to be based in their offices in Hertfordshire.The Role:To assist in the preparation of the nonclinical content for various global regulatory dossiers. This role will assist in the preparation of nonclinical regulatory dossiers including: • Global CTD dossiers for Established Products • Environmental Risk Assessments (ERA) • Clinical Trial Applications Key Responsibilities: * 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 * Where necessary, technical authoring of new CTD components to support in licensed/collaborative products. * Generation of nonclinical submission components to support established pharmaceutical products e.g. Label unification, ad hoc requests for information. * Authoring and coordinating the nonclinical components of regulatory documents such as Investigator brochures updates. * Facilitate construction of non-clinical documentation to support applications in China * Responding to requests for non-clinical documentation in a timely manner * Coordinating and preparing the nonclinical components of lifecycle documents * Comprehensive literature/information searches both externally and internally * Coordination with other disciplines e.g. Nonclinical development and CMC. * Preparation/review of tabular data summaries and study listings tables for ongoing submission support. Skills/Experience Required:Basic qualifications: Minimum graduate level, with a relevant biologically based scientific background. If you are interested in this role or would like to have a confidential discussion regarding other Regulatory Opportunities. Please contact me: or 01753 589673The recruiter has stated that all applicants for this job should be able to prove they are legally entitled to work in the EU/UK. SRG is a trading name of Science Recruitment Group Ltd an Employment Business/Agency.