Vincent Argiro, Rac Email and Phone Number
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Versatile regulatory affairs professional with strong knowledge of pre- and post-approval regulatory disciplines, including drug/device applications, dietary supplement notifications, label development, and promotional claim substantiation. Experienced in building and enhancing compliance infrastructures. Familiar with the concepts and practices of QA/QC as needed to successfully execute drug CMC submissions and navigate FDA inspections. Active member of multiple CHPA task groups and committees.
Prestige Consumer Healthcare
View- Website:
- prestigebrands.com
- Employees:
- 454
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Vice President, Quality Assurance And Regulatory AffairsPrestige Consumer HealthcareNew York, Ny, Us
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Associate Vice President, Regulatory AffairsPrestige Consumer Healthcare Apr 2024 - PresentTarrytown, New York, United States -
Senior Director, Regulatory AffairsPrestige Consumer Healthcare Apr 2022 - Apr 2024Tarrytown, New York, United StatesLeads a department responsible for the following in in the U.S., Canada, Latin America, and select Eastern markets:Determining the regulatory category, class, and application pathway for potential new productsDeveloping and reviewing new and revised product labeling Preparing technical documents for submission to regulatory agenciesReviewing promotional material and drafting claim support memos Providing input and oversight to clinical studies – including facilitation of IRB approval – as needed for claim support, consumer research, or marketing applicationsDefining and executing any necessary government notifications regarding product modifications, including drug listings, NDA supplements, and 510(k)sMonitoring the legislative landscape for coming changesParticipating in industry organizations and task groups to affect national policy
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Director, Regulatory AffairsPrestige Consumer Healthcare Sep 2014 - Apr 2022Tarrytown, NyLeads a department responsible for the following in relation to OTC drugs, medical devices, dietary supplements, and personal care products:Determining the regulatory category, class, and application pathway for potential new productsDeveloping and reviewing new and revised product labeling Preparing technical documents for submission to U.S. and Canadian regulatory agenciesReviewing promotional material and drafting claim support memos Providing input and oversight to clinical studies – including facilitation of IRB approval – as needed for claim support, consumer research, or marketing applicationsHandling global adverse event reporting and safety evaluations, including ingredients assessments Defining and executing any necessary government notifications regarding product modifications, including drug listings, NDA supplements, and 510(k)sMonitoring the legislative landscape for coming changesParticipating in industry organizations and task groups to affect national policy
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Manager, Regulatory AffairsPrestige Consumer Healthcare Jul 2012 - Sep 2014Greater New York City AreaExecuted all regulatory requirements of existing New Drug Applications (NDA)Provided regulatory direction on product positioning, labeling content, and advertising Provided technical support to U.S. safety & NPD initiativesResponsible for all elements of pharmacovigilance and adverse event reporting Monitored and communicated pending changes in regulatory requirements
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Senior Regulatory Affairs SpecialistPedinol Pharmacal Inc. Feb 2012 - Jul 2012Conducted Internal & External Quality Audits Wrote cGMP, PDMA, and Business Practice Standard Operating Procedures (SOP)Administered Compliance Training to All LevelsAdvised Executive Management on Regulatory Aspects of Product AcquisitionsCollected and Reviewed Documentation for NDA Annual ReportsOversaw Rx Sample Accountability ProgramOversaw Adverse Event Reporting ProgramPerformed Semi-Annual Review of Product ComplaintsConducted Regulatory Review of Marketing and Labeling MaterialsCoordinated Activities of Regulatory Consultants/Vendors -
Regulatory Affairs AssociatePedinol Pharmacal Inc. Jun 2006 - Feb 2012Administered Sales Force PDMA and Ethics TrainingAdministered cGMP Training to Warehouse Staff and Select ManagementWrote Regulatory/Quality Inspection ReportsDrafted Controlled Documents (SOP, Work Instructions, Tip Sheets, etc.)Conducted Preliminary Review of Marketing and Labeling MaterialsOversaw Adverse Event Reporting ProgramActed as Primary Contact for Sample Accountability Issues
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Assistant To The Director Of OperationsPedinol Pharmacal Inc. Jul 1998 - Jun 2006Farmingdale, NySupported the company's Distribution and Purchasing/Sourcing functions.
Vincent Argiro, Rac Skills
Vincent Argiro, Rac Education Details
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Summa Cum Laude
Frequently Asked Questions about Vincent Argiro, Rac
What company does Vincent Argiro, Rac work for?
Vincent Argiro, Rac works for Prestige Consumer Healthcare
What is Vincent Argiro, Rac's role at the current company?
Vincent Argiro, Rac's current role is Vice President, Quality Assurance and Regulatory Affairs.
What is Vincent Argiro, Rac's email address?
Vincent Argiro, Rac's email address is va****@****nol.com
What is Vincent Argiro, Rac's direct phone number?
Vincent Argiro, Rac's direct phone number is +191452*****
What schools did Vincent Argiro, Rac attend?
Vincent Argiro, Rac attended Purdue University Global.
What skills is Vincent Argiro, Rac known for?
Vincent Argiro, Rac has skills like Regulatory Affairs, Fda, Gmp, Adverse Event Reporting, Sop, Quality Auditing, Medical Devices, Recalls, Capa, Adobe Professional, Microsoft Office, Managed Care.
Who are Vincent Argiro, Rac's colleagues?
Vincent Argiro, Rac's colleagues are Martin James, Saurabh Kumar Chaturvedi, Reid Terch, Ariane Manuel, Joseph Kewley Sr, Brian Fisher, Mary Beth Fritz.
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