Rhona Osullivan
Senior Regulatory Affairs Specialist @BIP
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WORK HISTORY
Senior Regulatory Affairs Specialist @BIP
London, GB
Providing Regulatory Affairs project management consultancy to a global pharmaceutical client, creating and maintaining Regulatory Development Plans.Working with Regulatory Matrix Teams and Early/Medicine Development Teams to provide Regulatory functional line planning support and resource management to active Rx projects, spanning Commit to Candidate through post-approval R&D activities. Owning and providing active management of integrated Regulatory Development Plans, reflecting the Global Regulatory Strategy for individual Portfolio projects. Creating new project plans as required, and maintaining these, ensuring they continue to reflect the Global Regulatory Strategy as it evolves over time. This includes adding appropriate Regulatory deliverables, updating timelines, manipulating the interdependencies and logic in the plan to ensure accurate timelines that drive key Regulatory milestones. This includes engaging with PMs across the business to ensure cross-functional alignment of the various plans within the project group and communicate changes to the Reg strategy and timelines that impact other functional plans and the overall Medicine Development Plan (MDP) and supporting monthly and quarterly governance reviews with respect to strategic resource management and portfolio reviews.
EDUCATION
The Emmbrook School
A Levels, German, French, Economics, General Studies
University of Reading
Bachelor of Arts (BA), Sociology
SKILLS
ABOUT RHONA OSULLIVAN
Project & Programme Manager, with extensive experience within Regulatory Affairs in the pharmaceuticals, healthcare and technology. Worked cross functionally across global teams, to provide resource, budget and results-based planning and tracking across all areas. Collaborated with Stakeholders at all levels, to prepare appropriate visualisation of complex data sets, activities and compliance. Used diverse systems including Veeva Vault RIM, Planisware, MS Project & MS Project Online, Tableau, Power BI and SharePoint.• Highly organised with a proven track record in the timely delivery of high-profile complex solutions and programmes to budget• Experienced in building Project Management functions from the ground up that fulfil the needs of Stakeholders across the organisation and beyond• Excellent communication and stakeholder management skills, with a real passion for process improvement and change management• 20 years\' experience in delivering projects and programmes across the Pharmaceutical, NHS and Technology markets from concept to completion.• Member of ED & I Steering Committees and Employee Resource Networks for over 20 years• Treasurer and Head of Finance Committee for human rights charity Bisi Alimi Foundatio
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