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, amendments, Scientific Advice, post-approval) 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 (CTA/IND, annual reports, amendments, meetings, orphan designations, paediatric planning, marketing applications) Develops and/or reviews documents for submission to Regulatory Authorities and/or Ethics Committees Serve as representative of Global Regulatory Affairs at project team and business development meetings Works within a project team, and where necessary, leads projects Oversee and coordinate Regulatory Affairs Specialists to achieve submission targets Maintenance of project plans, project trackers, and regulatory intelligence tools Assist in development of Regulatory Affairs Specialists and other operational staff Provide input into regulatory strategy and timeline development for new study opportunities Establishes company standards to ensure quality of submitted information Maintains and executes on corporate quality initiatives Keeps abreast of laws, regulations, and guidelines governing drug development and approval Provides ICH GCP guidance, advice, and training Ability to understand clinical and pre-clinical study results for regulatory positions Knowledgeable of clinical trials methodology, protocols, and indications Knowledge and expertise with relevant regulations and guidance supporting pharmaceutical development Availability for domestic and international travel including overnight stays