Regulatory Compliance Specialist

Regulatory Compliance SpecialistIntegrated Resources, Inc is a premier staffing firm recognized as one of the tri-states most well-respected professional specialty firms. IRI has built its reputation on excellent service and integrity since its inception in 1996. Our mission centers on delivering only the best quality talent, the first time and every time. We provide quality resources in four specialty areas: Information Technology (IT), Clinical Research, Rehabilitation Therapy and Nursing.This position provides regulatory support in regards to several internal and external processes for the regulatory compliance of clients final products including: ingredient disclosure, Safety Data Sheets, WERCSmart, DOT hazardous materials shipping, US Customs, and the management of DEA controlled substances.This position reports to the Compliance Manager and will interface on a regular basis with the various internal regulatory staff. Other key stakeholders include Sales, Legal, R&D, Quality, Logistics Centers and Manufacturing sites.Key ResponsibilitiesCompliance Activity-Customs & Border, Controlled SubstancesSupport activity surrounding Import compliance for US Customs & Border, Health Canada, Transport CanadaSupport activity surrounding US DOT Hazardous Materials ShippingSupport activity surrounding to DEA Licensing for logistics centers and Year End Diversion tabulationSupport activity for FDA- ACE submissionsDatabase ManagementSupport maintenance of various databases including: clients internal ingredient disclosure database, clients website, TDS, Customs, and the external WERCS portal for product registrationProvide reliable interpretations of regulations and guidance documentsAssists in the tracking, archival and retrieval of regulatory information for website submissions/licensing following instructions from supervisorQualificationsBA/BS degree required in the natural or Life Sciences.1-2 years in the area related to Regulatory Affairs/Regulatory OperationsExperience in consumer products industry and DEA regulated products is highly preferredAble to read, understand, and apply regulations to company's activitiesDemonstrate a basic understanding of the rules governing development and approval of SDS, formulation, and Pharmaceuticals/Medical DevicesFamiliarity with the structure of a regulatory submissions via web portal and/or dossierHigh attention to detailExcellent database programming, word processing and computer skillsMust be team oriented and be able to work well with othersExhibit some independent problem solving skills on routine problemsAble to work independently and as part of a team within deadlines as imposed by internal guidelinesAbility to provide metrics/progress reports on project milestones