I am a strategic and detail-oriented Regulatory Lead with over 20 years of expertise in the successful delivery of Marketing Authorisation Applications (MAAs) and Post-Approval Lifecycle Management for conventional medicines with a successful proven track record in Variations, Renewals, PSURs, DSURs, and Notifications regulatory applications across EU and international markets.

My expertise ranges from Conventional Medicines, Generics, Speciality Products, Biotechnology Products and Advanced Therapy Medicinal Products (ATMPs).

I am an expert in navigating complex health authority regulations and requirements, consolidated by recent technical research into Advanced Therapy Medicinal Products (ATMPs) Regulation (EC) No 1394/2007, Biotechnology: Quality of Biotechnological Products (ICH Q5A – Q5E), and Clinical Trial Regulation EU 536/2014 Marketing Authorisation (Centralised and National Procedures) and Variation Regulation 1234/2008.

I apply Strategic Project Management to map complex regulatory systems and utilise strong communication skills to drive effective stakeholder negotiations. In addition, I can combine traditional regulatory strategies with a modern, data-driven toolkit (SQL, Python, R).

I apply Project Management to map complex systems and utilise strong communication skills to drive effective stakeholder negotiations. I can combine traditional project management strategies with a modern, data-driven toolkit (SQL, Python, R).

I have Project Management and Operational Expertise including:

  • Extensive track record of managing multiple, complex, cross-functional pharmaceutical projects from lead optimisation through regulatory submission, approval and implementation.

  • Recognised for driving high-performance outcomes in complex Product Lifecycle Management environments through proactive Issue Management and risk mitigation strategies.

  • Expert at identifying cross-functional bottlenecks and optimising the critical path for Established Product Portfolio Regulatory deliverables.

  • Proven ability to lead diverse teams by aligning project goals with organisational "big picture" objectives.

I am now seeking to transfer my project management skills to a suitable position.

My qualification/skills include:

  • BSc (Hons) Chemistry, HND Physical Science.

  • Counselling Diploma Level 3: Provider NIOQ | September 2025

  • Data Analytics: Advanced Excel, SQL, Data Cleaning, Data Mining and Data Analysis.

  • Programming: Python, Structure Query Language (SQL), and R.

  • Microsoft Office: Word, PowerPoint, OneNote, Access and Visio.

  • Project Management

Layide

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