Beatriz Teixeira
Oakville,ON
Summary
Clinical Research, Regulatory Affairs, Project Manager professional with over 10 years of experience working in large scale, multinational pharmaceutical companies. I am passionate about clinical research and looking for a career opportunity in this field.
Experienced with clinical trial monitoring and data integrity. Utilizes regulatory knowledge and protocol adherence to ensure successful study outcomes. Track record of effective collaboration and meticulous attention to detail in all aspects of clinical research.
Overview
23
23
years of professional experience
Work History
Supervisor
St. Andrew’s Catholic Elementary School
01.2024 - Current
Pharmacy Assistant
Bioscript Solutions
09.2022 - 12.2023
- The scope of this role includes filling prescriptions, making calls to patients, and maintaining the inflow of communication to the pharmacy email.
Director, Brand Development
Brand Institute
04.2021 - 08.2022
- Facilitated sales & new business opportunities.
- Prepared and presented boardroom PowerPoint brand strategy reports, brand name development workshops, marketing & safety research summaries, regulatory consultations, and submission documents primarily for the healthcare industry.
- Prospected, developed RFPs for public tenders in Canada.
Pharmacy Assistant
Shoppers Drug Mart
08.2020 - 04.2021
- Assisted in the preparation and dispensing of medications to patients.
- Liaised with healthcare providers to ensure accuracy of prescription information.
Administrative Assistant for Ales, Marketing and Logistics
Cosmolane Inc
01.2018 - 01.2019
- Responsible for forecasting and managing sales, logistics and monitoring stock. Also participated in marketing activities.
- Handled escalated calls efficiently, finding satisfactory resolutions for both customers and the company alike.
- Responded to customer requests for products, services, and company information.
- Resolved customer complaints with empathy, resulting in increased loyalty and repeat business.
Compliance Associate
GlaxoSmithkline Inc.
12.2012 - 03.2013
- Assisted in lifecycle management of Medical and RDO Divisional Standard Operating Procedures (SOPs) and guidance documents to meet corporate requirements.
- Supported project managers with systems and operational excellence.
- Assisted in audit & inspection readiness activities including compliance monitoring.
- Trainee program from the University of Toronto – temporary contract – 12 months
Project Manager
TEVA Canada Limited
04.2010 - 09.2010
- Successfully managed a project in record time with the objective of maintaining market share of the company’s extensive product line. The responsibilities for this project included:
- Managing daily activities of a project, providing leadership to the team and ensuring understanding of the objectives, specifications, activities, and project deadlines.
- Maintaining effective communication, performing "status reports", and ensuring adherence to the schedule through monitoring of all stages of the project life cycle.
- Following good practice standards and applying the lessons learned from previous projects.
- Conducting presentations and project reports to the project team and executive board of the company.
- Communicating project progress to stakeholders.
- Formally starting the project (kick-off), implementing the project schedule, performing the communication plan, and promoting the effective connection between the departments involved.
Senior Regulatory Affairs Associate
Apotex Inc.
11.2008 - 04.2009
- Prepare submissions to the US and Canada complying with the regulatory requirements of each country, as well as with pre-defined goals and deadlines by the company.
Regulatory Affairs Associate
Merck KGaA
01.2002 - 10.2008
- Coordinated regulatory requirements of markets in Latin America, with the Regulatory Affairs Departments in companies’ subsidiaries/partners of Latin America, to negotiate technical requirements and deadlines.
- Prepared ANDA and ANDS submissions, to Health Canada and FDA respectively, in e-CTD format, complying with pre-defined goals and deadlines of the company and its regulatory agency.
Regulatory Affairs/Clinical Research Lead
01.2002 - 01.2006
- Responsible for Planning, developing, and implementing requirements for the qualification of clinical research centers in Brazil to conduct clinical studies for the U.S. and Canada. This work allowed studies to be carried out in Brazil at half the cost of these studies done in Canada.
- Participated in GCP audits at research centers together with Clinimetrics (independent auditors) and Genpharm ULC (a subsidiary undertaking), seeking approval of clinical research studies conducted in Brazil by the FDA and Health Canada.
- Responsible for conducting, responding to regulatory questions, and approving clinical research studies for generic drug registration in Brazil.
- Monitored several clinical research studies, responsible for hiring and auditing clinical research centers according to the quality standards established by Anvisa, Health Canada and the company.
- Audited clinical research centers such as: Synchrophar, NuBee, Scentryphar, Paris&Paris, Hrim, ICF &, Unifag, Chromanalysis, Biocrom, and T&E Cartesius;
- Led, along with auditors of ANVISA, inspection of Clinical best practices aiming at certification for clinical research center located in India Medlar.
- Participation in numerous meetings and technical discussions with clinical research centers and ANVISA as a member of Pharmaceutical Industry Associations such as Febrafarma, Sinfar, e Câmara Técnica do CRF-RJ.
- Responsible for submission and approval of numerous generic products by ANVISA;
Education
Master's degree - Pharmaceutical Sciences
University of Toronto
11.2016
Specialization - Project Management
University of Toronto
01.2009
MBA - Business Management
Fundação Getúlio Vargas
01.2005
Bachelor's Degree - Pharmacy
UFRJ (Universidade Federal Do Rio De Janeiro)
01.2002
Skills
- ICH guidelines
- IRB submissions
- Clinical research coordination
- Informed consent process
- Project monitoring
- Site monitoring
- Monitoring visits
- Good clinical practice
- Completing regulatory documents
- Project management
Languages
Portuguese-fluent
English-fluent
Spanish-intermediate
Training
- Pharmaceutical Consulting - Rotman School of Business - 2011
- Pharmaceutical Strategy in Emerging Markets – Rotman School of Business - 2011
- Qualifying and Auditing Suppliers of Clinical Trials and Bioequivalence Studies- Febrafarma - 2003
Achievements
- 1. Clinical Research:
- Monitored, audited and qualified clinical research studies for Anvisa and Health Canada. Other achievements include:
- Planned, developed, and implemented requirements for the qualification of clinical research centers in Brazil to conduct clinical studies for the Canadian market. This work allowed studies to be carried out in Brazil at half the cost of these studies done in Canada.
- Supported Regulatory Affairs Specialists with the compilation of Clinical Trial Applications (CTA), submission and correspondence with Anvisa and Health Canada.
- Coordinated and approved numerous clinical research studies for product registration in Brazil.
- Responsible for Clinical research centers’ audits locally and abroad.
- Managed, mentored, and coached clinical research associates to their full capacity.
- 2. Regulatory Affairs
- Responsible for oversight and coordination of Latin American regulatory activities.
- Representative of the company in interactions with regulatory agencies and pharmaceutical industry associations.
- 3. Project management
- Managed a project with the objective of maintaining market share of the Company’s extensive line of products.
- Implemented new packaging to an extensive line of products, for private sale of the largest network of pharmacies in Canada. (The company surpassed its competitors and won the sale).
- Implemented, managed, and executed public tender applications and approvals in Canada.
Timeline
Supervisor
St. Andrew’s Catholic Elementary School
01.2024 - Current
Pharmacy Assistant
Bioscript Solutions
09.2022 - 12.2023
Director, Brand Development
Brand Institute
04.2021 - 08.2022
Pharmacy Assistant
Shoppers Drug Mart
08.2020 - 04.2021
Administrative Assistant for Ales, Marketing and Logistics
Cosmolane Inc
01.2018 - 01.2019
Compliance Associate
GlaxoSmithkline Inc.
12.2012 - 03.2013
Project Manager
TEVA Canada Limited
04.2010 - 09.2010
Senior Regulatory Affairs Associate
Apotex Inc.
11.2008 - 04.2009
Regulatory Affairs Associate
Merck KGaA
01.2002 - 10.2008
Regulatory Affairs/Clinical Research Lead
01.2002 - 01.2006
Specialization - Project Management
University of Toronto
MBA - Business Management
Fundação Getúlio Vargas
Master's degree - Pharmaceutical Sciences
University of Toronto
Bachelor's Degree - Pharmacy
UFRJ (Universidade Federal Do Rio De Janeiro)
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