The Role:Responsible for the coordination of all First Registrations, Renewals, Tenders, Response to questions and Site Registrations submissions. Ensuring delivery to agreed timelines and in...
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. E.g. Label unification, ad hoc requests for information.
Support the preparation of ERA documents which are required under the European Medicines Agency Regulation on Marketing Authorization Applications (MAAs), product line extensions, and license variations (EMEA/CHMP/ SWP/4447/00) or as requested by a non-European Union Agency to fulfil country specific requirements. The timely and accurate delivery of regulatory dossiers for the approval and maintenance of product marketing and clinical trials applications is a business critical activity. Authoring and coordinating the nonclinical components of regulatory documents such as Investigator brochures updates (IBs)
Life sciences degree and relevant experience or equivalent relevant experience.
Knowledge of Non Clinical Regulatory requirements (CTD guidelines), and ideally Environmental risk assessments.
Experience within searching Scientific Publication Databases
The 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.