Segren Bernard

WORK HISTORY

EDUCATION

ABOUT SEGREN BERNARD

Segren is a skilled regulatory affairs systems and process leader with over fifteen years’ experience in the life sciences and pharmaceutical sector. She has delivered many successful regulatory compliance programmes, focusing on regulatory information, dossier management and change control systems. She has extensive experience of the processes and systems required for compliant management of data and dossiers, including submission planning and tracking, dossier maintenance and submissions and maintenance of regulatory data sets. She excels at communicating vision and strategy and keeping stakeholders informed and engaged. Segren is both quality and delivery focused with a practical approach to problem-solving and a commitment to meeting the needs of the business.•Defining vision and strategy for regulatory affairs systems and processes, engaging with stakeholders at all levels•Analysis of cross-functional business processes, procedures and systems to improve business performance•Full project lifecycle experience including design, implementation, training and deployment of regulatory information management, change control and document management systems •Design, delivery and maintenance of regulatory information management, regulatory compliance and quality management systems and processes•Leadership of global teams, ability to communicate, collaborate and influence at all levels