Highly experienced Regulatory Professional adept at leading International Regulatory Agency submissions and interactions. Previous roles include European and Global Regulatory Leads, providing broad experience in all aspects of regulatory affairs.
Experience includes:
- Preparation of submissions for clinical trials, including Paediatric Investigation Plans, Orphan Designations, Biomarker and Marketing Authorisation applications for NCEs and biologicals
- Drafting of CMC/Quality, Non-Clinical and Clinical modules of regulatory dossiers
- Regulatory due diligence of new products, technology, business transfers or divestment
- Regulatory CMC Strategy
- Medical writing for clinical trials and regulatory submissions
