Wesley Smith Email & Phone Number

Utrecht, Netherlands

Amsterdam-Zuid, North Holland, Netherlands

Netherlands

Leiden, Zuid-Holland, Nederland

As an Associate Submission Manager, I played a pivotal role in ensuring the implementation of necessary regulatory strategies to meet country-specific requirements. My responsibilities encompass close coordination with a diverse cross-functional team, overseeing the compilation, publishing, and production of Clinical Trial Authorization Applications (CTAs), along with managing the complete lifecycle of associated CTA submissions.In this role, I have the dual responsibility of directly submitting CTAs to Health Authorities or facilitating the submissions through local personnel within specific countries. As a CTA Submission Manager, I serve as the main point of contact for interactions with Health Authorities, representing the organization in direct communications regarding CTA submissions.

Leiden, Zuid-Holland, Nederland

During my master's internship at Janssen, I centered my efforts on enhancing the interactions between Janssen and health authorities (HA). The primary objective of this project was to optimize the structure, clarity, and usability of a Health Authority Interaction database, facilitating its adoption by CMC Regulatory Affairs employees. The result of this initiative has empowered the CMC Regulatory Affairs team to efficiently store, retrieve, and align with past HA feedback, improving our consistency in current and future projects.In addition to my core responsibilities, I actively participated in biologic/vaccine-related CMC strategic workgroup meetings, took part in the preparation and review of regulatory documents, and contributed to products with PRIME (Priority Medicines) designated status. This multifaceted experience enabled me to broaden my knowledge of regulatory procedures in various departments, including lifecycle management and clinical development.

Leiden

My master's thesis primarily revolved around pioneering a cutting-edge approach for estimating protein pathway dynamics through the application of deep-learning Neural Networks. This endeavour involved meticulous data cleaning, processing, and dataset restructuring to ensure the generation of reliable and robust datasets.The core of this research hinged on determining whether the Neural Network could effectively capture the underlying dynamics of protein interactions within a biological pathway. To accomplish this, I developed a customized pipeline to enhance the Neural Network's capabilities. Ultimately, the project yielded a Neural Network proficient in predicting the impact of various protein changes.

Leiden

During my undergraduate research, I specialized in the field of big data analysis, where I conducted an in-depth investigation of databases containing information on cancerous point mutations and 'healthy' point mutation data. My responsibilities encompassed data processing, cleansing, and formatting to render these databases suitable for both quantitative and qualitative analyses. This comprehensive comparison led to the extraction of insights regarding mutation hotspots within kinases.I further executed a Pareto analysis to categorize the most promising point mutations for potential screening research. This analysis considered a unique array of variables to optimize decision-making. The outcomes of the Pareto optimization were subsequently applied to protein docking, enhancing our comprehension of the influence of point mutations on protein-ligand binding dynamics.

Master Of Science - Ms, Bio-Pharmaceutical Sciences

Bachelor Of Science - Bs, Bio-Pharmaceutical Sciences