Key Areas of Expertise:• Strategic Consultancy- Strategic advice; preparation, organisation and leadership of EMA and national agency meetings• Due Diligence- Conduct of regulatory due diligence on new product opportunities• Orphan Drug Designation/Paediatric Investigation Plans- Preparation and management of Orphan Designation and Paediatric Investigation Plans/Deferrals/Waivers • Clinical Trials- Preparation of Investigational Medicinal Product Dossiers. Preparation, submission and maintenance of Clinical Trial Applications• MAA Submissions & Licence Maintenance- Submission and approval of Marketing Authorisation Applications for New Active Substances using Centralised, Decentralised and MR procedures- Licence maintenance including line extensions, variations and renewals• Labelling- Preparation and management of Summary of Product Characteristics and Patient Information Leaflet

Key Areas of Expertise:• As above for Assensus Consulting GmbH

• leading, management and coaching a team of regulatory professionals• providing senior level oversight of regulatory strategies and procedures for cardiovascular & metabolism products from candidate selection through product lifecycle• member of European and International Regulatory Affairs Leadership Team• representing European and International Regulatory on Global Labelling Committee, Biomarker Advisory Board, Hepatotoxicity Board and Pregnancy Outcomes Advisory Panel• responsible for co-ordination and performance of European regulatory input into in-licensing opportunities • representing Regulatory Affairs on Global Medicines Development team for key late development asset

• leading, management and coaching a team of regulatory professionals• providing senior level oversight of regulatory strategies and procedures for musculoskeletal, inflammation, GI and urology products from candidate selection through product lifecycle• representing European and International Regulatory Affairs on Global Therapy Area strategic decision-making body• member of European and International Regulatory Affairs Leadership Team• representing European and International Regulatory Affairs on Portfolio Management Centre of Excellence• responsible for co-ordination and performance of European regulatory input into in-licensing opportunities • representing Regulatory Affairs on Global Medicines Development team for key late development asset

• provision of strategic and operational regulatory advice on all aspects of product development and maintenance as part of Global Project Teams • preparation and management of a variety of successful regulatory submissions, including new drug and clinical trial applications• leading, management and coaching a small team of regulatory professionals• led Global Regulatory Matrix team redesigning and optimising internal processes for providing global regulatory advice into Project Teams

• provision of strategic and operational regulatory advice on all aspects of product development and maintenance as part of Global Project Teams • preparation and management of a variety of successful regulatory submissions, including new drug and clinical trial applications• leading, management and coaching a small team of regulatory professionals• deputy leader of drug discovery Global Project Team

• Authored Nonclinical Pharmacology, ADME and Toxicology sections of global clinical trial and marketing applications (CTA, IND, MAA, NDA) for a broad range of therapy areas

Pharmacology and Biochemistry research in Anti-inflammatory Department.

Oncology and Rheumatoid Arthritis scientific research.