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Role Summary: The Head of Global Regulatory Operations manages the Global Regulatory Operations Team and the operational Outsource Partners. The role is accountable for the delivery of all regulatory submission filings and owns the strategy for all regulatory information management systems / processes.
The role reports to the Head of R&D Global Operations and is the subject matter expert aligned to Global Regulatory Affairs (GRA), is a member of the GRA Leadership Team and is a key contributor to the strategic direction of the business, eg. use of CRO panels, flexible resourcing strategies, etc.
• Direct and develop the Global Regulatory Operations team to efficiently deliver on all operational priorities in all regions: EU, USCAN, LatAm, EAGM, APAC. • Prioritize and balance operational workload to secure the best outcomes, take decisions to resolve complex issues, use experience and judgment to achieve all operational deadlines. • Oversee all business-critical submissions, strategies and plans, providing functional expertise to cross functional teams. • Be the subject matter expert for Health Authority requirements and for regulatory information systems: document management, submission publishing, registration tracking, submission planning, submission archiving, IDMP. • Drive process improvements, deliver new external mandatory requirements (eg. xEVMPD, IDMP) and new internal business initiatives (eg. simplification). • Direct outsource partners to execute on all work activities, to fulfill project objectives and to meet all Key Performance Indicators. • Oversee the development of processes, policies, guidelines, SOPs and Training Manuals. • Build Relationships with Industry Working Groups and Agencies to ensure future global, regional or national mandatory requirements are known and fulfilled.
Qualifications/Requirements: • Bachelor’s degree in a relevant scientific or Life Sciences discipline and/or significant experience in a Global Regulatory Operations leadership role or equivalent knowledge and experience. • Strong track record of Pharmaceutical / Life Sciences experience managing operationally focused activities or teams within Regulatory Affairs. • A working knowledge of Pharmaceutical Regulatory Submission requirements as defined by ICH and Global Health Authority Guidelines (FDA, EMA, etc.) • Ability to multitask effectively in a fast-paced environment with often shifting priorities. • Ability to work independently with minimal supervision or direction.
Applications from job seekers who require sponsorship to work in the UK are welcome and will be considered alongside all other applications. However, non-EU/EEA candidates may not be appointed to a post if a suitably qualified, experienced and skilled EU/EEA candidate is available to take up the post, as the employing body is unlikely, in these circumstances, to satisfy the Resident Labour Market Test. For further information please visit the UK Border Agency website
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