Experience

IVT Network, an Informa business

• Book and Periodical Publishing
• 1 - 100 Employee

• Editorial Advisory Board - Volunteer

  • Mar 2020 - Present

  Writer, reviewer, and editing contributor at Journal of GXP Compliance, an IVT Network publication. Writer, reviewer, and editing contributor at Journal of GXP Compliance, an IVT Network publication.



Temple University

• United States
• Higher Education
• 700 & Above Employee

• Adjunct Professor

  • Jan 2015 - Present

  Adjunct Professor, School of Pharmacy, QA/RA Master's Program: cGMP's for Pharmaceuticals, Global Drug Registration Requirements. Adjunct Professor, School of Pharmacy, QA/RA Master's Program: cGMP's for Pharmaceuticals, Global Drug Registration Requirements.



Janssen, Pharmaceutical Companies of Johnson and Johnson

• Associate Director, Regulatory Affairs-CMC - Small Molecule

  • May 2014 - Present

  • Management of Drug Master File/Active Substance Master File and other global dossier formats for small molecule Active Pharmaceutical Ingredients in the infectious disease and cardiology therapeutic areas, including CMC regulatory guidance and strategy to cross-functional, technical teams and portfolio management teams• Interaction with USFDA, EMA, Health Canada and other global health authorities; submission of dossier variations to support post-approval changes; responds to all HA CMC inquiries and requests for active pharmaceutical ingredient and related drug product support• Prepares and ensures accuracy of Modules 2.3 and 3 for dossiers; efficiency in using regulatory document repository for all simple and compound documents• Management of post-approval projects and initiatives in complex supply chains • Collaboration with external marketing partners to support the registrations and marketing authorization dossiers of drug products worldwide• Provides post-approval change control review, analysis and approval/rejection for change proposals Show less

• Associate Director, Regulatory Affairs-CMC - Large Molecule

  • Nov 2010 - May 2014

  • Responsible for CMC regulatory guidance and strategy to cross-functional post-approval, large molecule Immunology Biologics Teams; ensures appropriate CMC activities occur to support timely submissions• Management of post-approval projects and initiatives in complex supply chains for both formulated bulk/drug substance and drug product, from pre-culture through concentration and thawing/pooling through secondary bulk packaging• Working knowledge of attributes and regulations for devices using in conjunction with approved and marketed Immunology Biologics products Show less



Johnson & Johnson Consumer Company

• Manager, Associate Director, Regulatory Affairs

  • Oct 2004 - Nov 2010

  • Responsible for global regulatory guidance and strategy to Rx Dermatological and Oral Health franchises • Major project responsibilities include drug product manufacturing site changes, packaging and laboratory testing site changes, and qualification of new raw material and API suppliers • Regulatory document preparation and filing in paper-based/traditional and CTD formats • Liaison with USFDA, foreign regulatory authorities and ex-US regulatory consulting partners • Review and approval of company and department-specific Standard Operating Procedures Show less



Wyeth Consumer Healthcare

• Manager, Regulatory Affairs-CMC

  • Apr 2003 - Oct 2004

  • Regulatory CMC document preparation and filing: NDA, IND, Annual Reports, and Background Packages • Coordination of regulatory filings for company-wide site transfers and consolidation effort • Consumer product change control evaluation and approval for various marketed OTC and dietary supplement products • Provide regulatory support for external industry groups • Regulatory CMC document preparation and filing: NDA, IND, Annual Reports, and Background Packages • Coordination of regulatory filings for company-wide site transfers and consolidation effort • Consumer product change control evaluation and approval for various marketed OTC and dietary supplement products • Provide regulatory support for external industry groups