Regulatory Manager/ Senior Regulatory Manager (Clinical Trials)

Bachelors degree, or equivalent experience, ideally in a scientific or healthcare discipline 5 years Regulatory experience required for the Manager level 7 years Regulatory experience required for the Senior Manager Regulatory level Computer literacy (MS Office/ Office 365) Fluent in English Regulatory affairs experience working for a Clinical Research Organisation Experience leading Clinical Submissions Informed knowledge of all aspects of the drug development process inclusive of regulatory milestones Specialized knowledge of regulatory activities for at least one major region (EU, US) including submissions to Regulatory Authorities, INDs/CTAs and amendments, Scientific Advice Procedures, and post-approval submissions Ability to understand clinical and pre-clinical study results, to help in its interpretation for regulatory positions and strategy Knowledgeable of clinical trials methodology, including a working knowledge of protocols and indications being studied Knowledge and expertise with relevant regulations and guidance supporting pharmaceutical development Availability for domestic and international travel including overnight stays

Provides regulatory guidance throughout the clinical development life cycle Compile, coordinate and review applications to Regulatory Authorities including CTA/IND, annual reports, amendments, scientific advice/regulatory authority meetings, orphan designations, paediatric planning, and marketing applications Develops and/or reviews documents intended for submission to the Regulatory Authorities and/or Ethics Committees Serve as representative of Global Regulatory Affairs at project team meetings Works within a project team, and where necessary, leads project for the region or globally Oversee and coordinate Regulatory Affairs Specialists Maintenance of project plans, project trackers and regulatory intelligence tools Assist in development of Regulatory Affairs Specialists and other operational area staff Provide input into regulatory strategy and timeline development Assists in establishing company standards Participates in maintaining and executing on the corporate quality initiatives Keeps abreast of laws, regulations and guidelines governing drug development and approval Provides ICH GCP guidance, advice and training Serve as representative of Global Regulatory Affairs at business development meetings