Adeline Rahardja
Winnipeg,Canada
Summary
Hardworking and dedicated Regulatory Affairs Specialist successful at preparing and documenting regulatory paperwork. Tireless in maintaining current understanding of legal regulations in order to keep all products compliant. Bringing 10 years of pharmaceutical/natural health products experience and seeking a growth-oriented position.
Overview
13
13
years of professional experience
Work History
Senior Regulatory Affairs Specialist
Vita Health Products Inc
Winnipeg, Manitoba
02.2024 - Current
- Responsible for OTC drugs, NHPs, and food product life cycle management
- Prepare and compile regulatory submissions for new DINs and NPNs, as well as correspondences in accordance with Health Canada regulations, guidelines and their interpretation
- Maintain and update Drug Establishment Licenses (DEL)/Site Licences (SL) according to business needs
- Review and provide feedback on regulatory documents, such as applications for marketing authorizations, variations, renewals
- Prepare, review and liaise with Quality group to prepare Product Specification for OTC drugs and NHPs in accordance to USP and NHP quality guidance
- Provide regulatory assessment for labelling and packaging non-conformance and change controls to ensure compliance
- Provide regulatory assessment for replacement product and vendor resourcing
- Review and maintain product certifications, as well as any changes to the current definition of GMO and allergen status
- Maintain and update Annual Drug Notifications for new products’ launches, dormant and marketed products
- Review and keep up-to-date with scientific or regulatory policies in related to OTC drugs, NHPs and foods.
Regulatory Affairs Specialist
Vita Health Products Inc
Winnipeg, Manitoba
09.2018 - 02.2024
- Maintained records of all regulatory filings and correspondence.
- Collaborated closely with cross-functional teams on product design, manufacturing processes, quality assurance.
- Reviewed and compiled regulatory documents to ensure compliance with Canadian regulations.
- Coordinated submission of product applications to Canadian regulatory agencies.
- Assisted in the preparation of technical documentation for registration submissions.
- Facilitated communication between internal departments and external stakeholders.
- Prepared responses to inquiries from regulators regarding product safety or efficacy issues.
Method Validation Specialist
03.2016 - 09.2018
- Design and perform method development, verification, transfer and validation studies as required
- Prepare validation documents including study protocols, memos, and reports
- Data collection and analysis including statistical evaluation for validation projects
- Review, research and analyze Pharmacopeias (USP, EP) methods and requirements as required for validation studies
- Ensure compliance to all compendia and cGMP requirements
- Maintain current knowledge in the areas of compliance, validation and other regulatory issues
- Initiate Change Controls and Deviations as required
- Write, edit and update STMs
- Assists in problem identification and troubleshoots with other Departments as required
- Conduct material specifications requirements as required.
Quality Control Analyst
Apotex Fermentation
Winnipeg, Manitoba
01.2012 - 03.2016
- Design and perform stability study and reference standard certification as per ICH Guideline
- Perform quality control testing of raw materials, in-process, finished intermediates, and final product
- Compile test results and analyze data
- Prepare documents including study protocols, change controls, reports, SOPs, memos, Non-Conformance Material Release (NCMR), SCAR (Supplier Correction Action Request) and OOS/OOT investigation reports
- Input and track trending specification for stability study and reference standard certification
- Input and track updates on new and expired standards, as well as re-certification of standards
- Prepare Analytical Reports and Certificate of Analysis for finished intermediates and final product release, as well as reference standards
- Release and rejection of in-process, finished intermediates, and final products
- Conduct qualification testing of utilities, vendors, and equipments
- Participate in problem identification, deviations and perform corrective actions in accordance to cGMP
- Perform cross training on new employees.
Food Labelling Compliance Support
Bakkavor Fresh Foods
Brampton, Ontario
10.2010 - 03.2011
- Compile nutritional data information from vendors
- Input and prepare Nutrition Facts labels for new product recipes using Genesis software
- Act as an intermediary to Bakkavor’s partners
- Review food labelling claims on products’ ingredients
- Provide regulatory guidance on food labelling to vendors
- Ensure compliances between policy and regulation requirements.
Education
MSc - Food Safety and Quality Assurance
University of Guelph
BSc - Food Science
University of Manitoba
Skills
- Policy Analysis, Plain Language Initiatives for OTC and NHPs
- Impact Assessment
- Technical Guidance
- Forms Management
- Consumer Inquiry Management
- Data Verification
- Labeling Requirements
- Stakeholder Communication
- Regulatory Submissions (eCTD non-eCTD, REP, epost)
- Audits
- Product Information
- Technical Documentation
- Risk Management
- Project Management
- Planning, time management, communication and organization skills
- Report writing skills
- Knowledge of basic statistical analysis
- Computer skills; proficient in MS Word, Excel, Power Point, Outlook, Lotus Notes
- A team player
- Detail-oriented; skilled at analyzing data and preparing reports
- Able to multi-task
- Fluent in English and Bahasa (Indonesia)
- Basic understanding of French language
References
Available upon request
Timeline
Senior Regulatory Affairs Specialist
Vita Health Products Inc
02.2024 - Current
Regulatory Affairs Specialist
Vita Health Products Inc
09.2018 - 02.2024
Method Validation Specialist
03.2016 - 09.2018
Quality Control Analyst
Apotex Fermentation
01.2012 - 03.2016
Food Labelling Compliance Support
Bakkavor Fresh Foods
10.2010 - 03.2011
MSc - Food Safety and Quality Assurance
University of Guelph
BSc - Food Science
University of Manitoba
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