Regulatory Manager

Bachelors degree, or equivalent experience, ideally in a scientific or healthcare discipline Computer literacy (MS Office/ Office 365) Fluent in English Graduate, postgraduate Possesses basic understanding of financial management 5 + years or more relevant regulatory affairs experience 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) Ability to understand clinical and pre-clinical study results Knowledgeable of clinical trials methodology Knowledge and expertise with relevant regulations and guidance supporting pharmaceutical development Availability for domestic and international travel including overnight stays Strong interpersonal skills Demonstrates an acceptable degree of professionalism Ability to manage multiple and varied tasks Exhibits high self-motivation Motivates other members of the project team Flexible attitude with respect to work assignments Resolves project related problems and prioritize workload to meet deadlines Focuses on continuous improvement Collects data of consistently high standard Communicates both verbally and in written form Conducts formal presentations to a wide variety of audiences

Provides regulatory guidance throughout the clinical development life cycle Compile, coordinate and review applications to Regulatory Authorities 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 to achieve submission targets Maintenance of project plans, project trackers and regulatory intelligence tools Assist in development of Regulatory Affairs Specialists and other operational area staff Provide input, as required, into regulatory strategy and timeline development Assists in establishing company standards to ensure the highest quality of submitted information Participates in maintaining and executing on the corporate quality initiatives Keeps abreast and continually expand knowledge of laws, regulations and guidelines governing drug development and approval Provides ICH GCP guidance, advice and training to internal and external clients Serve as representative of Global Regulatory Affairs at business development meetings