Crowthorne, England, United Kingdom
• Responsible for ensuring that teams and functional groups are provided with clear, constructive regulatory advice and intelligence to assist planning and issue resolution during product development and registration. • Plans and implements regulatory activities in support of lifecycle management and maintenance in the region. Identifies compliance risks proactively. • Supports co-ordination of the review of CMC, QRD, PSUR and labelling submissions and approval of product-related packaging as required to ensure regulatory compliance. • Provides appropriate Europe Region regulatory input to project teams and Global Regulatory Slides via the Global Liaison and Global Regulatory Teams. o Ensures planned drug development activities comply with guidelines and in cases where they do not provides a critical analysis of the risks and issues. o Makes recommendations to Global Regulatory and drug development teams in order to shape the global strategy in line with regional/commercial objectives o Supports the drug development strategy; defining options for Scientific Advice/PIP/IMPD, creating briefing packages and co-ordinating and supporting EU agency meetings. o Defines Europe Region filing strategy (including CP, MRP, DCP); identifying risks and issues. • Responsible for implementing and ensuring effective planning, tracking, archiving of activities, especially submissions, internal memos and key correspondence. Ensures effective planning and tracking of activities via RIM system. • Supports the communication of regulatory strategy in support of new product registration, in line with commercial objectives. • Support implementation of new processes and input into changes in processes, as required • Responsible for the Notification of Regulatory activities and related database entry/data accuracy for allocated projects.