Roz has been with NDA since 2010 and specialises in European and Global Regulatory Affairs from early development to lifecycle management, with particular emphasis on Regulatory strategy. Helping clients across the product life cycle from input into development target profiles at a non-clinical stage to end of life cycle defence strategies.
Key Areas Of Expertise
- Extensive knowledge and expertise of the EU regulatory systems
- Experienced in National, Centralised and Mutual Recognition procedures both initial applications and line extensions and Scientific Advice (national and EMA).
- NCE and established product experience.
- Experienced in National and EMA Scientific Advice, PIP, ODD, Gap analyses.
- Due diligence assessment of potential in-licensing opportunities.
- Project lead and Agency contact specialising in Clinical section of dossier.
- Drug/device combination products
- OTC switch assessments
- Extensive experience in global Regulatory Agency interactions and leading face to face Agency meetings in both a product and an industry capacity.
- Regulatory experience in a number of therapeutic areas including Oncology, Cardiovascular, Metabolism, Pulmonary, CNS and Inflammation, small molecules, biotech. and drug/device combinations.
Responsible either in a Project specialist capacity or as a Therapeutic Area Director for the initial EU registration of 5 NCEs plus multiple line extensions (clinical indication/ new presentations) together with an MAA for a drug/device product.
Roz worked in European and International Regulatory Affairs within the Pharmaceutical industry for 23 years in senior positions in multinational companies, managing large groups of up to 165 regulatory professionals in central and affiliate offices.
Roz has a PhD. Neurophysiology, B.Sc. (Hons.) Physiology and Biochemistry.