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) Possesses 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) Ability to understand clinical and pre-clinical study results and assist in their 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 Strong interpersonal skills Ability to contribute to a team environment Demonstrates professionalism, punctuality, and ability to deliver on commitments Ability to manage multiple and varied tasks in a fast-moving environment Good record-keeping skills High self-motivation and ability to work and plan independently and in a team environment Ability to motivate other members of the project team Flexible attitude with respect to work assignments and new learning Ability to resolve project related problems and prioritize workload to meet deadlines with little support Focus on continuous improvement and proactive assessment of processes Ability to collect data of consistently high standard Ability to communicate both verbally and in written form Ability to conduct formal presentations to a wide variety of audiences with high proficiency

Provides regulatory development advice and guidance for optimal conduct of clinical trials Ensures timely preparation of quality regulatory submissions in compliance with applicable regulations Coordinates and prepares regulatory documents for submission to Regulatory Authorities and/or Ethics Committees Maintains current knowledge of regulations and guidance documents, providing analysis to project teams Supports and enhances the corporate Regulatory function Compiles, coordinates, and reviews applications to Regulatory Authorities (CTA/IND, annual reports, amendments, etc.) Develops and/or reviews documents for submission to Regulatory Authorities and/or Ethics Committees Serves as representative of Global Regulatory Affairs at project team and business development meetings Leads projects for the region or globally where necessary Oversees and coordinates Regulatory Affairs Specialists to achieve submission targets Maintains project plans, trackers, and regulatory intelligence tools Assists in development of Regulatory Affairs Specialists and other operational staff Provides input into regulatory strategy and timeline development Assists in establishing company standards for submitted information Participates in maintaining and executing corporate quality initiatives Keeps abreast of laws, regulations, and guidelines governing drug development and approval Provides ICH GCP guidance, advice, and training