Responsible for maintaining strong partner relationships to support the delivery of strategically important partnered programs.

Prepared global regulatory submissions to support licensure of recombinant coagulation products.Collaborated with colleagues in the US, Europe and Japan.Designed databases to enable the compilation and analysis of agency feedback on global marketing submissions to enhance the development of future products.Provided regulatory support and advice to early clinical development programmes to facilitate the development of novel breakthrough therapies.Conducted regulatory intelligence to identify new regulations, guidelines and agency feedback on competitor products.

Prepared regulatory submissions to support clinical trials and licensure of recombinant products.Provided regulatory and scientific advice to Core Project Teams and Expert Teams to achieve cost effective and optimal outcomes for Recombinant Product Development.Conducted global regulatory intelligence to keep abreast of regulatory requirements and competitor activities.

Co-ordination and preparation of R&D regulatory project plans, pathways and processes. Prepared Regulatory Position PapersProvided support for compilation and review of regulatory submissions.Provided support for cross functional team planning.Assisted in the transfer of Regulatory Affairs activities to colleagues in the USA.Monitored and reported milestones and project progress.Developed project planning and monitoring tools.Organised team building offsite for Regulatory Affairs department.

Prepared IND and IMPD regulatory submissions to support clinical trials using a novel vaccine adjuvant.Prepared Type II Master File to maintain proprietary manufacturing information.Collaborated with colleagues at manufacturing site in the USA.Assisted in analytical assay development and transfer.Reviewed R&D protocols and reports.Prepared local working practices.

Established a database to manage all stages of the commissioning, review and publishing process.Commissioned a multidisciplinary study which received international coverage in over 30 publications including the New York Times, Sydney Morning Herald, Science and Nature.Prepared in-house genetics style guide.Responsible for line management of commissioning editors.

Fully responsible for content acquisition and quality.Researched and prepared monthly news updates.Helped to establish PGBase, a comprehensive pharmacogenomics database.

Researched and developed novel antagonistic molecules to potentially treat human growth disorders.