OVERVIEW
FOCUS AREAS
Medical Devices & Combination Products
International Regulatory Affairs for Medicines
Regulatory Affairs professional with experience across both human medicines and medical devices. Able to demonstrate excellent tactical and operational awareness to help support local, regional and global partners, ensuring multiple regulatory objectives are met under tight timelines. Hands on experience of CMC Gap Analysis, NTA to CTD conversions, performing quality checks on regulatory documents, project management and reviewing QMS for medical devices
Engaging with regulatory strategic planning and management of deliverables across the global team. Committed to continually developing and building a credible professional rapport with regulators and stakeholders. Strong communication, interpersonal and organisational skills with project management experience.
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EDUCATION:
First Class Honours Degree in PhysicsCERTIFICATION
Green Belt CERTIFICATIONS: in Medical Devices -
AREAS OF EXPERTISE:
CMC Gap Analysis:
NTA to CTD conversions
Conduct QC of regulatory documents including briefing books, Orphan drug and scientific advice document.
Document management for submissions
End-to-end RA support and project management to assigned multi disciplinary project teams.
Remain abreast of local and International Regulations and Standards, in accordance with role and projects
Regulatory Intelligence research
Experience with QMS compliance with MDR 2017/745
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