Laura Troscolan Email & Phone Number

Mississauga, Ontario, Canada

Toronto, Ontario, Canada

As part of the Global Regulatory Affairs CMC team, I worked on US, Canadian, European, and International regulatory submissions to maintain license and registration files of various vaccine products. I collected, analyzed, and prepared necessary data and documentation for CMC regulatory submissions, including variations, amendments, supplements, and response to questions.Achievements:• Collaborated across site functions to prepare CMC regulatory submissions for US, Canada, Europe, and international markets in the CTD format, maintaining license and registration files for various vaccine products • Authored CMC Sections (Module 2 and Module 3) for a variety of regulatory submissions, including variations, amendments, supplements, and response to questions• Prepared regulatory assessments and regulatory strategy documents for international submissions• Collaborated and analyzed information expeditiously from appropriate departments to ensure the timely preparation of response to questions from regulatory authorities and supply-critical submissions• Performed activities surrounding license conformance as the Quality role and Regulatory Affairs role• Ensured maintenance and filing of regulatory-related documentation and tracked regulatory commitments, submissions requests, and deliverables in Veeva Vault

Mississauga, Ontario, Canada

As a Manufacturing Specialist, I was involved in end-to-end manufacturing operations related to upstream process development for new client projects.Achievements:• Identified and drove continuous improvement initiatives improving compliance with SOPs ahead of Health Canada audit• Involved in technology transfer for new projects; drafted and revised controlled documentation including BOMs, BPRs, SOPs, and WINs in collaboration with the client, QA, and QC departments• Supported validation activities (IQ/OQ/PQs) for new biomanufacturing equipment, collaborating with Engineering, Facilities, and Validation departments to ensure the timely and compliant execution of protocols• Qualified trainer on upstream manufacturing equipment; provided hands-on technical training to operators• Operated, among others the following manufacturing equipment: biosafety cabinets, centrifuges, incubators, bioreactors (5L, 50L, 500L, 2000L), cell culture analyzers

Cambridge, Ontario, Canada

In this role, I conducted day-to-day R&D, and quality control tasks in the manufacturing processes for current and new dry mix sports nutrition and dietary supplementary beverages.Achievements:• Completed production runs of sports nutrition supplements in compliance with cGMPs, including batching and blending ingredients, setting up and operating the all-fill machine• Assisted in day-to-day product development processes; improved the flavours of current sports nutrition supplements and secured new customer revenue• Devised a system for inventory management on retained samples in the warehouse

Newmarket, Ontario, Canada

In this role, I managed a high volume of time-sensitive operational drinking water samples weekly while also completing regular field sampling and continuous improvement projects. Achievements:• Conducted laboratory testing on the chemical and microbiological parameters of drinking water, such as ATP, nitrite, iron, pH, and total coliform counts • Reported on the operation of drinking water systems using data obtained from SCADA to update process review sheets and summarize trends• Maintained the operations lab by calibrating and cleaning testing equipment, taking inventory, ordering supplies, and cleaning up chemical spills • Coordinated field sampling at eight different groundwater treatment facilities for simulated distribution system testing of iron and manganese sequestration • Summarized findings in eight comprehensive reports which helped operators determine whether silicate dosing should be increased at specific facilities

Ontario, Canada

As a Food Technologist at Maple Leaf Foods, I worked with Product Developers in the ThinkFood lab to develop new and delicious meat protein products.Achievements:• Planned tests/trials/protocols for NSERC project, culminating in a successful presentation in front of the Research & Development team• Developed meat protein products in a kitchen benchtop and pilot plant environment, from raw ingredients to final products, following formulations and specifications • Operated pilot plant machinery independently following an initial training period

Ontario, Canada

I was tasked to begin the process of implementing and analyzing nutritional facts table and ingredient decks as part of Health Canada’s reformation coming into effect in 2021.Achievements:• Spear-headed project on information and product analysis for updating products label information as per new Health Canada nutritional regulations • Generated nutritional tables using Genesis for products and ingredients not requiring lab analysis• Organized and maintained a comprehensive excel document of nutritional lab results • Knowledgeable of SOPs, Risk Assessments, HACCP plans, and trained in food safety

Mississauga, On

• Taught RCM level Music History to a young student who passed with Honours• Taught beginner piano lessons to children aged 6-10• Created and adapted lesson plans to student abilities

Graduate Certificate, Pharmaceutical Regulatory Affairs And Quality Operations (Raqc), 4.0

• President’s Honour List in Winter 2023 semester in recognition of outstanding academic achievement • Gained a thorough knowledge.

Honours Bachelor Of Science (B.Sc.), Biochemistry (Co-Op)

Activities and Societies: CBS Literature Review Club Multi-disciplinary curriculum that gives students broad exposure to the life sciences.

Regional Arts Program

Activities and Societies: Jazz-a-peel, Ritz, Les Belles • Awarded Ontario Scholar for a cumulative average of above 80% • Graduated.