Highly experienced Regulatory Professional adept at leading International Regulatory Agency submissions and interactions. Previous roles include European and Global Regulatory Leads, providing broad experience that is highly valuable to small and medium enterprises who require experience in all aspects of regulatory affairs.
Skills include:
- Preparation of submissions for clinical trials, including Paediatric Investigation Plans, Orphan Designations, Biomarker and Marketing Authorisation applications for new chemical entities and biologicals
- Medical writing for clinical trials and regulatory submissions
- Populating CMC/Quality, Non-Clinical and Clinical sections of regulatory dossiers
- Performing quality audits as Responsible Person and leading CAPA analysis and correction activities
- Due diligence of new products, technology, business transfers or divestment.
