Louise Slater
Regulatory Affairs Manager @Amgen
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WORK HISTORY
Regulatory Affairs Manager @Amgen
Cambridge, GB
Support the EU Regulatory Lead with assigned clinical trials in the Oncology portfolio. Be responsible for planning, preparation, submission and management of EU CTR applications including initial submissions, modifications, closures, notifications etc. for several studies in the Oncology portfolio- Attend and provide input to clinical study team and global regulatory team meetings. Review/ author initial/ updated clinical study documents, propose/ contribute to submission strategy and guide study teams through EU CTR submission requirements/ procedural steps/ timelines, responses to RFIs (authoring text where possible) and submission of intermediate/ final summary of results reports in CTIS- Ensure submission planning, preparation and archiving in Amgen RIM, follow policies, procedures and SOPs, and support Oncology/ General Medicine team members including sharing knowledge/ learnings in EU CTR coordination group/ EU RL surgery meetings
EDUCATION
Imperial College London
Doctor of Philosophy (PhD), Respiratory Medicine
Northumbria University
BSc (Hons) Biomedical Science, Molecular Biology
SKILLS
ABOUT LOUISE SLATER
A self-motivated, enthusiastic Regulatory Affairs Manager with a \"can-do\" approach. Highly driven by challenges and goals, with a proven ability to work both independently and as part of a team. Organised, thorough and methodical in nature with an excellent ability to multi-task and to product work with the highest attention to detail and accuracy. Excellent oral and written communication skills with a clear, concise and informative writing style. Always enthusiastic to learn, improve and progress.
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