RANCY ANN THOMAS
Brampton,ON
Summary
Self-motivated Regulatory Affairs Associate holding 2 years of pharmaceutical industry work experience. Excellent project management abilities, including facilitation, organization and time management. Talented at providing regulatory leadership for new product development and change management activities. Self-motivated Regulatory Affairs Associate holding [Number] years of pharmaceutical industry work experience. Excellent project management abilities, including facilitation, organization and time management. Talented at providing regulatory leadership for new product development and change management activities.
Overview
3
3
years of professional experience
Work History
Regulatory Affairs Associate
Cliantha Research
03.2024 - 06.2024
- Prepared and submitted regulatory documents, including CTAs, notifications, amendments, SNDSs, and NDS contributions, ensuring compliance with ICH, regional requirements, and company policies
- Managed pharmaceuticals and medical devices regulatory change assessments and regulatory submissions to Health Canada and maintained related documentations
- Assessed product-related claims and coordinated substantiation dossiers
- Contributed to local process improvements impacting CMC Regulatory Affairs function and other departments
- Collaborated with cross-functional partners (Medical Affairs, Technical Application Group, Quality, Legal, US and global counterparts) for assigned brands including natural health products and general foods
- Contributed to the foundation of Regulatory team by maintaining compliance tools, updating policies and procedures, and striving for continuous improvement
- Kept abreast of Canadian regulatory environment and significant international developments from health agencies (such as the US FDA), scientific authorities (such as IOM and EFSA), and international standard-setting organizations, sharing regulatory knowledge internally.
Project Management Associate
Axiom Real Time Metrics
04.2022 - 03.2024
- Facilitated clinical studies project management activities from start-up to close-out, including study timelines, database configuration and developing supporting materials
- Acted as primary point of contact for sponsors and CROs/Vendors ensuring timely responses and resolutions
- Led weekly client teleconferences, ad-hoc calls and prepared materials such as meeting agendas, project status tracker, minutes
- Assisted in eCRF module design and configuration and propose timelines for GO Live
- Collaborated with cross-functional teams (Data Management, Patient Safety, Quality Assurance, Regulatory, Finance) to align on data requirements and system translations
- Led financial management efforts for studies, overseeing monthly invoice preparation and review, and managing additional client requests and out-of-scope tasks.
Regulatory Affairs Intern
Cliantha Research
04.2021 - 08.2021
- Maintained comprehensive knowledge of clinical trials/clinical research and industry regulatory requirements
- Stayed current on regulatory updates and issued regular communications bulletins
- Supported preparation, review and submission of applications to regulatory agencies in Canada (CTAs, and related applications) for clinical trials
- Communicated with regulatory agencies (Health Canada, FDA) and sponsors in response to regulatory issues raised in documents such as clarifaxes or deficiency letters.
Education
Associate of Applied Science - Clinical Research & Regulatory Affairs
Academy of Applied Pharmaceutical Sciences
Ontario, Canada05.2021
Ph.D. - Biochemistry
Bharathiar University
India06.2016
Master of Science - Biochemistry
Bharathiar University
India04.2007
Skills
- Regulatory compliance and conformance
- Change Control Process Management
- Health Canada Regulatory Submissions
- ICH, GCP, cGMP guidelines
- Clinical data abstraction and eCRF management
- Research Ethics Board submissions
- CMC Data analysis and Compilation (Biologics, Pharmaceuticals)
- Critical analysis of Scientific data
- Excellent oral and written communication skills
- Proficient in Microsoft Excel
- Excellent organizational and prioritization skills
- Attention to detail
Websites
Timeline
Regulatory Affairs Associate
Cliantha Research
03.2024 - 06.2024
Project Management Associate
Axiom Real Time Metrics
04.2022 - 03.2024
Regulatory Affairs Intern
Cliantha Research
04.2021 - 08.2021
Associate of Applied Science - Clinical Research & Regulatory Affairs
Academy of Applied Pharmaceutical Sciences
Ph.D. - Biochemistry
Bharathiar University
Master of Science - Biochemistry
Bharathiar University
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