Experience

• 

  H-d graphix

  May 2007 - Jul 2021

  Graphic artist
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  Dr. reddy's laboratories

  Nov 2008 - May 2014

  • Customer Service Representative

    Jan 2014 - May 2014

  • Senior Label Specialist

    Nov 2008 - Jan 2014
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  Alcon

  May 2014 - Feb 2018

  Labeling specialist ii
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  Alchemee (formerly the proactiv company)

  Feb 2018 - Oct 2022

  Regulatory affairs specialist

  Change (NC), DIN applications, PDC [Post-authorization Division 1 Change], Labelling-only submissions, Administrative submissions, clarifax responses, Annual Notifications). • Served as Subject Matter Expert on PLL (Plain Language Labelling) regulations for Health Canada.• Key opinion leader for the new company branding project. • Provided regulatory evaluations and comments on Post-NOC and Post-DIN quality changes.• Experienced in electronic common technical document (eCTD) publishing and sequence management.• Assisted with establishing PIFs (Product Information Files) for the cosmetic product line in the EU market.• Submitted and updated product dossiers successfully through the EU Service portal.• Per the European GDP Guideline, temporarily assigned as the RP for cosmetic product lines in the EU market. Show less

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  New world medical

  Jul 2022 - Nov 2023

  Product packaging labeling designer

  • Reviewed and quality-checked surgical primary and secondary product packaging components.• Worked on re-structuring EU-MDR product labeling for multiple product lines.• Communicated with external translation companies and ensured the quality and accuracy of information was delivered on time.• Worked with cross-functional departments to ensure alignment on product compliance and oversee that documents were routed on time within the Product Lifecycle Management system. • Supported engineers with updating drawing specifications to comply with the latest EU-MDR regulations and standards.• Developed electronic request forms for new product development and sustaining packaging content using Adobe Creative Cloud, Microsoft Power Automate, TVT (Text Verification Tool), and SharePoint.• Followed all department processes and procedures to coordinate and execute deliverables.• Engaged with colleagues to complete validation reports according to country-specific requirements.• Initiated change controls within change management system. Show less

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  Sgs & co

  Dec 2023 - now

  Regulatory affairs specialist
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  Naturich labs, inc.

  Jul 2024 - now

  Regulatory affairs specialist