BEVIN DE SILVA
London
Summary
Passionate about regulatory excellence and compliance, I am eager to leverage my experience in regulatory affairs to make a meaningful impact in the industry. Experienced with regulatory affairs, scientific procedures and consulting.
Overview
4
4
years of professional experience
Work History
Regulatory Classifier, DAQ Unit
Medicinal Health Regulation Agency (MHRA)
11.2022 - Current
- Processed global regulatory applications for medicines. Covering National, MRP and IRP Procedures. Experienced in Type IA, Type IB, and Type II variations.
- Advised applicants on regulatory guidelines and classification of changes (A, B, C change codes). Providing solutions regarding incorrect documentation (e.g Certificate of Suitability, PRAC assessment reports, SPC etc.) , eCTD structure and labelling activities.
- Monitored and maintained regulatory standards to comply with national and international regulations.
- Assessed regulatory submissions ensuring Modules 1-5 contain the correct data, SPC's and PIL are updated in line with the reference product and dossiers are compliant with MHRA submission guidelines.
- Liaised with external and internal stakeholders to support efficient application approval rate. Achieving a 98% on-time rate.
- Fully certified in regulatory validation systems. (EURS & Lorenz). Consulted applicants on how to overcome issues regarding sequences and product lifecycle.
- Worked collaboratively with cross-functional teams, including the Clinical Trials Unit, Renewals Unit, and Initials Unit, to gather critical information for pending applications, .
Associate Consultant
Discover International, Executive Search LTD
07.2022 - 11.2022
- Life Science Consultant specialising in medical and clinical recruitment, successfully placing professionals within leading pharmaceutical companies (Lundbeck, Novartis and GSK) and CROs across Europe.
- Conducted extensive market research within the pharmaceutical industry across the EMEA region, analysing trends and innovations to stay ahead of market developments.
- Sourced, engaged, and negotiated with European clients and professionals. Successfully closed a €170k deal with Lundbeck for a Director-level placement
- Actively involved in business development and marketing, including drafting business emails, creating job descriptions, and promoting services to potential clients.
- Developed and implemented new strategies to enhance client engagement and strengthen professional relationships.
Medical Laboratory Assistant
Sonic Healthcare
11.2020 - 06.2022
- Performed laboratory tests across the haematology, biochemistry, and virology department. Gained real-time experience with drug development and scientific data.
- Utilised the Laboratory Information Management System (LIMS) to maintain test logs, ensuring compliance with the Data Protection Act and safeguarding patient privacy.
- Conducted investigative reports and collaborated with various departments to resolve invalid results and customer enquiries.
- Trained new colleagues, monitored team progress and ensured targets were consistently met.
- During the height of the pandemic, processed over 600 samples daily, including PPCR, APT, GWS, and PWS samples, demonstrating efficiency and adaptability.
Education
BSc - Neuroscience
University of Nottingham
06-2020
A Level’s - Biology, Psychology, Chemistry
Ilford County Grammar School
01.2017
Skills
- Regulatory submissions
- Validation protocols
- Labeling requirements
- Stakeholder communication
- Relationship building
- Standard operating procedures
- Documentation compliance
Languages
English, Spanish, Italian
Native language
Timeline
Regulatory Classifier, DAQ Unit
Medicinal Health Regulation Agency (MHRA)
11.2022 - Current
Associate Consultant
Discover International, Executive Search LTD
07.2022 - 11.2022
Medical Laboratory Assistant
Sonic Healthcare
11.2020 - 06.2022
A Level’s - Biology, Psychology, Chemistry
Ilford County Grammar School
BSc - Neuroscience
University of Nottingham
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