OVERVIEW
FOCUS AREAS
Regulatory Affairs Manager with 4+ years of experience supporting clients with multi-regional projects at different stages of drug development from pre to post approval.
International regulatory strategy for EU and US-based companies.
Product registration
Llife-cycle management of rare disease products
EU/UK and emerging markets, particularly Middle East and North Africa
Regulatory Affairs and Medical Writing professional with a proven ability to demonstrate strategic thinking and planning, a methodical approach to problem solving and effective client communication.
Hands on experience of managing multi-regional projects and providing partnership support with client distributors and affiliates, with a proven track record in navigating complex international regulatory landscapes to provide strategic leadership.
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EDUCATION:
Biochemistry BSc (Hons) Firstclass honours degree King’s College London -
AREAS OF EXPERTISE:
Mentoring, training and management of junior employees.
International Regulatory Lead within EU and US-based companies to support EU/FDA approved products also used in conjunction with Medical Devices.
Product registration and life-cycle management of rare disease products within emerging markets, particularly within Middle East/North Africa (MENA).
Knowledge of and familiarity with the procedures, regulations and practices of EU and International regulatory agencies.
Brexit lead to non-EU/International markets.
Review and coordination of updates to Summary of Product Characteristics and Labelling based on CCDS revisions.
Experience in writing Clinical Study Reports, Patient Narratives, and Module 2 Clinical and Non-Clinical Overviews.
Maintaining effective direct communication with key stakeholders and affiliates.
Development of successful tools for project tracking and management.
Planning search strategies, and the systematic review and classification of literature output for product line extensions.
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