**MAIN PURPOSE OF ROLE** + Experienced professional individual contributor that works under limited supervision. + Applies subject matter knowledge in the area of Regulatory Affairs. + Requires capacity to apply skills/knowledge within the context of specific needs or requirements. **MAIN RESPONSIBILITIES** + AstheExperiencedprofessionalintheRegulatoryAffairs Sub-Function,possesseswelldevelopedskillsindirectingdevelopmentofproductregistrationsubmission,progressreports,supplements,amendments,orperiodicexperiencereports. + Interactswithregulatoryagencytoexpediteapprovalofpendingregistration. + Servesasregulatoryliaisonthroughoutproductlifecycle. + Participatesinsomeofthefollowing:productplandevelopmentandimplementation,regulatorystrategy,riskmanagement,chemistrymanufacturingcontrol(CMC). + Ensurestimelyapprovalofnewdrugs,biologicsormedicaldevicesandcontinuedapprovalofmarketedproducts. + Servesasregulatoryrepresentativetomarketing,researchteamsandregulatoryagencies. + Advisesdevelopmentand/ormarketingteamsonmanufacturingchanges,lineextensions,technicallabeling,appropriateregulationsandinterpretations. **QUALIFICATIONS** **Education** + AssociatesDegree(± 13years) **Experience/Background** + Minimum 1 year An Equal Opportunity Employer Abbot welcomes and encourages diversity in our workforce. We provide reasonable accommodation to qualified individuals with disabilities. To request accommodation, please call 224-667-4913 or email corpjat@abbott.com