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 (preferred) Basic understanding of financial management (preferred) 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) 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

Provide regulatory development advice and guidance for optimal conduct of clinical trials. Ensure timely preparation of quality regulatory submissions in compliance with applicable regulations. Coordinate and prepare regulatory documents for submission to Regulatory Authorities and/or Ethics Committees. Maintain current knowledge of regulations and guidance documents. Provide analysis to project teams. Support and enhance corporate Regulatory function. Provide regulatory guidance throughout the clinical development life cycle. Compile, coordinate, and review applications to Regulatory Authorities. Develop and/or review documents intended for submission to Regulatory Authorities and/or Ethics Committees. Serve as representative of Global Regulatory Affairs at project team meetings. Lead projects for the region or globally where necessary. Oversee and coordinate Regulatory Affairs Specialists to achieve submission targets. Maintain 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 for new study opportunities. Assist in establishing company standards to ensure highest quality of submitted information. Participate in maintaining and executing on corporate quality initiatives. Keep abreast of laws, regulations, and guidelines governing drug development and approval. Provide ICH GCP guidance, advice, and training. Serve as representative of Global Regulatory Affairs at business development meetings.