Current position and relevant professional experience:
My current job title is strategist, oncology, global regulatory affairs at Merck Healthcare R&D. I have over 20 years' experience in pharma with several roles in both regulatory affairs and clinical operations ranging from in-house CRO, regulatory consultant for pharma, and in-house roles in pharma. I have worked as regulatory and ethics submission associate, regulatory submissions project management, and in-house regulatory development strategist.
I have experience working internationally, both UK (5 years) and EU (Germany, 15 years). Currently I am responsible for an oncology portfolio at Merck Healthcare and lead development strategy for a well-established marketed product in international markets. I also lead strategy in EU and international on several PoC development molecules.
On a procedural level, from 2022-2025 I lead implementation of an operating model in the run-up to the clinical trials regulation go-live.
Current or previous involvement in TOPRA activities:
I am co-chair of the TOPRA Clinical Trials Special Interest Network SPIN, I organise a range of activities and we hold monthly discussion calls with regulatory professionals to help achieve information exchange on clinical trial regulatory affairs topics of interest.
I am also a mentor as part of TOPRA's expanded offering for individuals interested in a career in regulatory affairs.
I have chaired sessions on the topic of clinical trials at the TOPRA Symposium in October 2019 and 2022 and an industry speaker at the TOPRA Symposium in October 2018. I will chair a session on clinical trials/ biotech act at the upcoming TOPRA Symposium, October 2026.
I have also published in and contributed to TOPRA's Regulatory Rapporteur journal, see below:
The EU Clinical Trial Regulation (EU) No 536/2014 The Clinical Trials Information System (CTIS) Regulatory Rapporteur, April 2021 Price, C; Schmilt, E.; Vromans, L.; DeJager, H.; Bhatti, S.
Strategic considerations for implementing the revised EMA guideline on FIH clinical trials. Regulatory Rapporteur, June 2019 Schmitt, E.; Vromans, L.; Bagchus, W.; Roesener, S.; Amexis, G.; Price, C.; Bhatti, S.
Personal statement:
I have benefited first hand in my career from the offerings of TOPRA as a very good support network for all who are professionals in regulatory affairs. However like any organisation it is in need to evolve, modernise and increase engagement with those who are new to the industry to remain at the cutting edge. With a focus on international team collaboration, open communication, flexibility and attention to detail, I would welcome the opportunity to support that evolution.