Benjamin Arcaira

Experience

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  Innodata Inc.

  Jul 2012 - Oct 2012

  Drug Information Writer

  - Review the package insert of drugs and create reports such as drug interaction/adverse event index, concise product monographs, and label updates summary in accord with the US Physicians' Desk Reference editorial guideline.

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  Pointwest Innovations Corporation

  Apr 2013 - Apr 2014

  Clinical Specialist I

  - Engaged in pharmacy benefit management performing requirements intake assessment, drug coverage analysis, clinical consultative services, and clinical coding.

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  Novartis

  Sept 2014 - May 2020

  - Support product lifecycle management of the Pharma portfolio through timely renewal of marketing authorizations and submission of post-approval changes, eg, CMC variations, Core Data Sheet/safety label updates.- Maintain up-to-date regulatory information of products in internal systems and database.- Perform other tasks necessary in the performance of business, eg, timely renewal of company license to operate, maintain valid cGMP clearance for foreign manufacturing sites, and obtain narcotics permit for controlled preparations. Show less

  • Regulatory Affairs Specialist

    Mar 2016 - May 2020

  • Drug Regulatory Affairs Assistant

    Sept 2014 - Feb 2016
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  Procter & Gamble

  Jun 2020 - now

  - Drive and execute regulatory strategy for Consumer Health innovation and base business projects in partnership with multifunctional teams.- Maintain regulatory compliant business through timely license renewals, review of packaging artworks and promotional materials, performing as regulatory subject matter expert; point of contact to Health Authorities during queries and in-market situation.- Analyze impact of new regulations and changing regulatory landscape and help drive business compliance.- Actively collaborate with industry associations (PAPPI, HADSAP) for policy shaping advocacies.- Experience with human drugs, medical devices, food, and health supplements. Show less

  • Senior Regulatory Affairs Manager, Personal Health Care

    Dec 2024 - now

  • Regulatory Affairs Manager, Personal Health Care

    Jun 2020 - Dec 2024