Current position and relevant professional experience:
I have worked as a CMC regulatory professional for the past 15 years and currently a Director in the Global CMC department at Pfizer UK R&D Limited. I support CMC teams and global regulatory submissions in the biologics field and manage a team of 10 colleagues. The role involves the training and development of staff as well as supporting the regulatory CMC aspects across the lifecycle for oncology projects. In the past I supported global CMC submissions for small molecules and managed a team of regional regulatory strategists with a focus on the EU. I work with colleagues across technical lines as well as global regulatory leads. As part of my role supporting projects I have engaged with regulators in the EU, US and Asia.
Current or previous involvement in TOPRA activities:
I have been actively involved in TOPRA for many years, during which I have contributed at several levels. I am currently a co-Chair of the CMC SPIN steering committee, having previously been the Chair. This year I have been involved in the organisation of the CMC session for the TOPRA Annual Symposium and will be on the speakers. In the past I was a member of the CRED CMC working party, including Chair, and a member of the Regulatory Rapporteur editorial team for several years.
For 4 years I was the EU board representative and in this capacity worked with the TOPRA office in setting up TOPRA In groups in Austria, France, Germany, Ireland, Italy, Sweden and Switzerland. I chaired meetings within these groups to support local meetings.
Personal statement:
I bring 24 years' experience in the pharmaceutical industry, including 15 years in a regulatory CMC position supporting small molecules and biologics. I have developed an in-depth knowledge through regulatory submissions, meetings with regulatory agencies and engagement in the external regulatory environment. Through my volunteering activities with TOPRA (CMC SPIN, Regulatory Rapporteur, CMC CRED course, past EU Board representative) I have had an opportunity to understand the organisation and the benefits it brings to regulatory professionals. With this knowledge and experience, my past commitment to TOPRA and ongoing contributions, I believe I can assist TOPRA via membership of the board.
Nomination information
Proposer: Sylvia Lobo; Seconders: Martin Lanigan, Dipesh Mistry