Karen Gwozdowski Gauvin

Associate Director, Regulatory Compliance (Private Brands) @Chewy

Boston, MA, US
MOBILE NUMBERS
+91 *********19

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WORK HISTORY

Oct 2021 — Present

Associate Director, Regulatory Compliance (Private Brands) @Chewy

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Primary focus is on Chewy Private Brands Consumables, Healthcare, Premium, and Specialty Consumables products- Oversee completion of state licenses, product registrations, license and product renewals, and tonnage reporting for new and renovated products- Serve as liaison between Chewy Private Brands and regulatory agencies and industry organizations (e.g, AAFCO, States, FDA, EPA, NASC, PFI)- Review packaging/labeling and product detail page (PDP) related content for compliance with regulations and requirements- Conduct research on product and claim regulatory requirements, and provide recommendations and guidance to cross-functional partners- Monitor for potential new and updated regulations, and create and implement compliance strategies related to new and updated regulations- Identify, assess, and communicate regulatory requirements, constraints, trends, risks, and opportunities related to Chewy Private Brands to numerous teams and cross-functional partners (e.g, legal, R&D, sourcing, marketing)- Provide consultative support to Chewy Private Brands team as needed regarding regulatory-related questions and concerns (e.g, ingredient naming, testing requirements, corporate social responsibility)- Manage and mentor the Regulatory Compliance Manager to ensure the team is achieving the team and organization goals, is in compliance with both corporate and regulatory requirements, and is able to continue to develop and grow while dealing with constantly changing priorities

EDUCATION

2000 — 2002

University of Massachusetts Amherst

MPH, Epidemiology

1995 — 1999

Clark University

BA, Biology/Microbiology

SKILLS

21 Cfr Part 11Regulatory SubmissionsQuality AssurancePmaPost Market SurveillanceGcpClinical DevelopmentSoftware DocumentationCtmsRegulatory RequirementsIndRegulatory AffairsLifesciencesQuality AuditingIso 13485Clinical TrialsPharmaceutical IndustrySopFdaMedical DevicesClinical ResearchCapaU.s. Food and Drug Administration (Fda)Cross-Functional Team LeadershipIso 14971BiotechnologyValidationPharmacovigilanceGmp

ABOUT KAREN GWOZDOWSKI GAUVIN

Regulatory compliance associate director with over 15 years of experience in regulatory affairs, compliance, quality systems, auditing and clinical trial management in the consumer product, medical device, pharmaceutical (OTC and prescription), in vitro diagnostic, and biologic industries. Versatile professional with over 5 years of leadership and management experience in regulatory compliance and quality assurance. In-depth experience with development of regulatory strategies and submissions, interfacing with regulatory agencies, managing cross-functional and multi-national project teams, international standards, risk management, and auditing of large and small companies.

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Karen Gwozdowski Gauvin — Associate Director, Regulatory Compliance (Private Brands) at Chewy in Boston, MA, US | Unifers