Anne Nguyen, RAC

Project Manager, Regulatory Affairs at Paladin Labs
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Contact Information
us****@****om
(386) 825-5501
Location
Montreal, Quebec, Canada, CA
Languages
  • French Native or bilingual proficiency
  • English Native or bilingual proficiency
  • Vietnamese Native or bilingual proficiency
Skills

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Kerry D.

I had the pleasure of working with Anne for the past year.She is very intelligent and speaks with proffessionalism. Anne was motivated to excel in her role and I am confident that she would be an asset to any organization. I highly recommend her without hesitation!

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Credentials

  • RAC-Canada
    Regulatory Affairs Certification Program
    Dec, 2013
    - Sep, 2024

Experience

  • Paladin Labs
    • Canada
    • Pharmaceutical Manufacturing
    • 100 - 200 Employee
    • Project Manager, Regulatory Affairs
      • Apr 2022 - Present

      - Maintain regulatory compliance for approved products during the post-marketing phase;- Manage the preparation of quality regulatory submissions according to predefined timelines;- Review scientific data and documents to ensure compliance with Canadian regulations and all relevant guidelines and policies;- Review product labels to ensure compliance with Canadian regulations;- Assume responsibility for the registration of new, assigned products;- Provide regulatory advice and liaise with other internal departments and external partners;- Participate in the planning and implementation of regulatory strategies;- Compiles regulatory files in eCTD format using Docubridge and submit to Health Authorities.

  • Duchesnay
    • Canada
    • Pharmaceutical Manufacturing
    • 1 - 100 Employee
    • Senior Associate, Regulatory Affairs
      • Jan 2020 - Apr 2022

      - Regulatory Lead for multiple products- Regulatory Lead for 21 countries in Europe- Prepare briefing package and assist to meetings with health agencies- Planify, organize and submit regulatory submissions (NDS, NDA, CTA, IND, medical devices)- Prepare regulatory amendments (SNDS, NC, PAS, CBE)- Research, analyze, interpret and apply regulations, directives and international politics- Review promotional material and labels- Development of SOPs- Review content of clinical and R&D documents- Lead for Docubridge, document management system- Liaise with external partners and consultants

    • Associate Regulatory Affairs
      • Jul 2017 - Jan 2020

      - Planify, organize and submit regulatory submissions (NDS, NDA, ANDA, DINA, CTA, IND, medical devices)- Submission of 2 Canadian NDS including one for a rare disease- Prepare regulatory amendments (SNDS, NC, PAS, CBE)- Research, analyze, interpret and apply regulations, directives and international politics- Review promotional material and labels- Update and submit product monographs to CPS- Development of SOPs- Review content of clinical and R&D documents- Liaise with external partners and consultants

  • Shire
    • Japan
    • Biotechnology Research
    • 700 & Above Employee
    • Senior Regulatory Affairs Specialist/Canada Regulatory Product Specialist
      • May 2015 - Jul 2017

      - Prepare and submit Health Canada submissions, including content / structure definition, preparation / review / collection of components and submission review- Draft, coordinate regional labeling review and perform quality control review of Product Monograph and labeling texts- Review printed packaging component artwork- Assist in the review of promotional / non-promotional materials- Review and interpret relevant legislation, guidance and codes- Prepare briefing package and meeting-related materials for Health Canada meeting and assist and present to the meeting- Provide local input into assessment of CMC change controls- Liaise with Global departments and provide Canadian specific regulatory input

  • Jubilant DraxImage
    • Canada
    • Pharmaceutical Manufacturing
    • 1 - 100 Employee
    • Regulatory Affairs Specialist
      • Mar 2014 - May 2015

      - Resource person for eCTD submissions - Prepare, review, analyze and consolidate all relevant pharmaceutical and related technical information required for the registration of the company’s drug products with Regulatory Agencies- Prepare computer-based submission summaries- Ensure compliance with government regulations by providing agencies with all necessary pharmaceutical and technical information relating to changes or modifications of the company’s products- Prepare technical and regulatory information in order to maintain the company's licences

  • MedXL Inc.
    • Canada
    • Hospitals and Health Care
    • 1 - 100 Employee
    • Regulatory Affairs Associate
      • Sep 2013 - Feb 2014

      - Management of MedXL's products in Canada and South America (Colombia, Mexico, Brazil, Argentina, Uruguay)- Submission of new medical device licences- Post-market activities (medical device licence amendments, recalls (if necessary), importation processes for international markets)- DIN submissions- Interactions with Health Canada and consultants from Emergo, Arazy Group- Conduct internal audits for the company - Management of MedXL's products in Canada and South America (Colombia, Mexico, Brazil, Argentina, Uruguay)- Submission of new medical device licences- Post-market activities (medical device licence amendments, recalls (if necessary), importation processes for international markets)- DIN submissions- Interactions with Health Canada and consultants from Emergo, Arazy Group- Conduct internal audits for the company

  • Pharmascience
    • Canada
    • Pharmaceutical Manufacturing
    • 700 & Above Employee
    • Publisher, Regulatory Operations
      • Aug 2012 - Sep 2013

      - Produce regulatory submissions in compliance with ICH and regional format requirements- Delivery of published and validated regulatory submissions that meet internal and external paper & electronic format requirements- Lifecycle management of regulatory submissions- Writing of SOPs and Best Practices- Process Improvement - Produce regulatory submissions in compliance with ICH and regional format requirements- Delivery of published and validated regulatory submissions that meet internal and external paper & electronic format requirements- Lifecycle management of regulatory submissions- Writing of SOPs and Best Practices- Process Improvement

  • Bio-K+ International Inc.
    • Clinical Research Associate (Part Time)
      • Sep 2011 - Aug 2012

      - Scientific research for health professionals and consumers- Writing of 2 scientific papers and other documents intended for health professionals- Assist the clinical research manager for the supervision of a clinical study- Participation in Expo-Manger Santé Montréal 2012 - Scientific research for health professionals and consumers- Writing of 2 scientific papers and other documents intended for health professionals- Assist the clinical research manager for the supervision of a clinical study- Participation in Expo-Manger Santé Montréal 2012

Education

  • Université de Montréal / University of Montreal
    Post-Graduate Diploma, Drugs' Development
    2011 - 2013
  • Université de Sherbrooke
    Bachelor, Pharmacology
    2008 - 2011
  • Cegep de Maisonneuve
    D.E.C., Health Sciences
    2006 - 2008

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