EVA BLAJA
Greater Ottawa Area,ON
Summary
Experienced Regulatory Affairs Officer with a track record of delivering results over 5 years. Skilled in developing effective processes and executing regulatory affairs initiatives for Clinical Trials in the Pharmaceutical and Biotechnological industries in Canada. Improved processes and supported product development to meet regulatory requirements, ensuring compliance and efficiency. Demonstrated expertise in maintaining and following up on records of regulatory information and submissions. Additional experience includes 5 years in the biotech industry and over 10 years in Quality Assurance, project implementation, and change management for Clinical Skills assessments in Canada.
Overview
19
19
years of professional experience
Work History
Regulatory Affairs Specialist
Alimentiv Inc.
Ottawa - London - Remote, ON
01.2024 - Current
- Worked effectively in fast-paced environments.
- Skilled at working independently and collaboratively in a team environment.
- Proven ability to learn quickly and adapt to new situations.
- Excellent communication skills, both verbal and written.
- Worked well in a team setting, providing support and guidance.
- Demonstrated respect, friendliness and willingness to help wherever needed.
- Assisted with day-to-day operations, working efficiently and productively with all team members.
- Managed time efficiently in order to complete all tasks within deadlines.
Regulatory Affairs Specialist- Clinical Trial Applications Manager
ICON PLC (Clinical Research)
07.2022 - 01.2024
- Lead regulatory support to Clinical Trial teams- multi-discipline studies
- Manage regulatory submissions to ensure compliance with Health Canada guidelines
- Give the green light for Product shipment to the clinical study sites
- Validate Investigational product labels according to local regulations
- Coordinate and lead the preparations for urgent requests from Health Canada and applicable Ethics Committees
- Deal with all change management aspects related to Clinical Trial development and applications.
- Achievements: More than 150 regulatory submissions approved by Health Canada. Answered and received positive feedback on more than 100 Information Requests issued by Regulatory Authorities
Regulatory Affairs Specialist
Brunel on assignment with Sanofi
10.2021 - 07.2022
- Maintain, update and Quality Control of Regulatory Affairs filing documentation to Health Canada
- Prepare regulatory binders for submissions
- Track all Product Information (REP PI) version updates in appropriate database
- Check and update the Patent list
- Run and analyze foreign safety notification reports and prepare summary to the Manager
- Prepared Product Information form for Vaccines.
Clinical Skills Assessment Coordinator-bilingual (EN/FR)
Medical Council of Canada
09.2005 - 06.2021
- Coordinating various projects in clinical assessments throughout all phases, specifically in quality assurance and risk assessments in a highly stressful and constantly changing environment
- Coordinating change management initiatives driven by Covid-19 situation affected enterprise operations
- Developing, maintaining, reviewing business documentation, policies, and procedures, creating risk registers and reports, maintaining Good Documentation Practices
- Overseeing, following, abiding by all provincial medical regulators' policies all government, legal rules, and regulations to ensure compliance
- Maintaining the post-exam review of test items performance material
- Liaising with the various stakeholders, such as senior medical advisers, academia and psychometricians to discuss any unclear points on clinical examination content
- Ensuring the accuracy of the listing of the medical terminology on exam materials
- Overseeing item bank entries post medical proofing, group review and post-exam.
Education
Regulatory Affairs – RAC Ontario College Graduate Certificate (w Honours) - Regulatory Affairs - Sciences
Algonquin College
Ottawa Ontario06.2021
M.D. - Biophysics Engineering
National Research Nuclear University
Moscow, Russia01.2005
Skills
- Written Communication
- Decision-Making
- Teamwork and Collaboration
- Basic Math
- Remote Office Availability
- Project Planning
- Critical Thinking
- Attention to Detail
- Calm Under Pressure
- Organizational Skills
Affiliations
- Regulatory Affairs Professionals Society | RAPS – member in a good standing
- Ontario Society of Professional Engineers (OSPE) – member in good standing
- Association of Translators and Interpreters of Ontario – member in good standing
Certifications Training
- Medical Terminology for Health professionals - 2016
- English language business writing course - 2015
- French language specialization course - 2004-2005
- Management capacity building courses - 2000
Volunteer Experience
Health Care Interpreter, Richmond Lodge Nursing home, 2005, present
References
REFERENCES AVAILABLE ON MY LINKEDIN PROFILE
Languages
English
Bilingual or Proficient (C2)
French
Advanced (C1)
Georgian
Upper intermediate (B2)
Russian
Bilingual or Proficient (C2)
Romanian
Upper intermediate (B2)
Work Preference
Work Type
Part TimeFull TimeContract WorkWork Location
RemoteImportant To Me
Flexible work hoursWork-life balanceWork Availability
monday
tuesday
wednesday
thursday
friday
saturday
sunday
morning
afternoon
evening
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Accomplishments
More than 150 successful Regulatory Clinical Trial Application submissions to Health Canada
More than 100 successful applications to Ethics Committees in Canada and USA
Success in submission to Ethics Committees in Mexico (7 submissions)
Timeline
Regulatory Affairs Specialist
Alimentiv Inc.
01.2024 - Current
Regulatory Affairs Specialist- Clinical Trial Applications Manager
ICON PLC (Clinical Research)
07.2022 - 01.2024
Regulatory Affairs Specialist
Brunel on assignment with Sanofi
10.2021 - 07.2022
Clinical Skills Assessment Coordinator-bilingual (EN/FR)
Medical Council of Canada
09.2005 - 06.2021
Regulatory Affairs – RAC Ontario College Graduate Certificate (w Honours) - Regulatory Affairs - Sciences
Algonquin College
M.D. - Biophysics Engineering
National Research Nuclear University
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