Advisor -Regulatory Compliance and Post Market

Regulatory Compliance And Post Market Reporting Team MemberAt Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We're looking for people who are determined to make life better for people around the world.This position is responsible for providing GMP/GxP support across the different regulatory reporting and inspection support that is provided by the RCPMR (Regulatory Compliance and Post Market Reporting) team. This includes but is not limited to; all facets of inspections for all global Health Authorities. Support HA reporting (FAR, BPDR, OUS requirements). Provide support for global recall and US recall activities, monitoring and reporting of US product shortages, coordinate product shortage notification for OUS countries, update drug and device establishment registrations for changes as the need arises including completion of annual changes.In this role the individual provides support that they provide to the different programs are as shown below. Primary focus is compliance support; other duties will depend on business needs.Lead inspection readiness activitiesServe as a global compliance CGMP expert providing feedback in preparation for corporate audits, agency inspections, global standard revisions, and changes in local business or manufacturing processes.Proficient in application and use of Machine Learning and analytical tools to being continuously in a state of inspection ready.US (Field Alert Report-FAR, Biological Product Deviation Report-BPDR, EUA reporting, Illegitimate Product Report - Form 3911 per DSCSA) and Global regulatory reporting of Quality/safety/compliance issuesWorks with numerous stakeholders to ensure HA reporting as required to meet all Global regulations/requirementsGlobal and US Recall / Market WithdrawalSupports the coordination of the execution activities related to US product recall and withdrawals.Participate in periodic product withdrawal/recall simulations.Consult and train local recall coordinators to assure understanding of process for product removal.Monitors recall activities of partner organizations globally.Provide information for use in various periodic reviews or metrics.Global and US Product ShortageCoordinate and execute product shortage reporting for US and OUS: Includes networking with Supply chain, Global Quality Leaders, Senior Management, Legal, Regulatory, Global Patient Safety, Qualified Persons at Affiliates and others as appropriate to determine the need and document the decision for FDA reporting or for notification to OUS regulatory agencies Generate, submit and maintain product shortage documentation following local procedure.Provide information for use in various periodic reviews or metrics.Drug and Device Establishment RegistrationDetermine information required for drug and device establishment registration for all manufacturers of US marketed product, such as importers, agent, and function.Update drug and device establishment registrations for changes as required including completion of annual registrations.US Volume ReportingCoordinate and execute annual volume reporting for US.Provide information for use in various periodic reviews or metrics.Personal Development and Shared LearningBe continually aware of current industry trends and regulatory agency interpretation of GMP and other relevant requirementsContinue to gain knowledge vital to provide a greater understanding of GxP requirementsParticipate in applicable external industry groups and forumsMinimum Requirements:Bachelor's degree - Preferred degree in a scientific field such as Pharmacy, Chemistry, Engineering or other biological sciences.Minimum of 5 years relevant Industry or Health Authority experience in areas which may include: technical services, manufacturing operations, quality assurance, quality control or regulatory affairsAdditional Preferences:Broad knowledge of GMPs and quality systems for pharmaceutical manufacturing and marketingExpertise in data driven approaches to assess site complianceExperience in Quality Assurance or GxP functionStrong compliance knowledgeExcellent communication and presentation skills: ability to deliver constructive feedbackSkilled in interpreting and applying standards to diverse situations with strong problem-solving abilityAbility to work independently and collaboratively with minimal supervisionSignificant experience supporting global inspections and compliance programsOther Information:Maintain awareness of regulatory and industry tends; ensure corporate standards remain current.Flexibility to effectively prioritize work activities to meet regulated timelines.Ability to influence and negotiate with peers, immediate supervision, site supervision and executive management.Must be available to travel (domestic and international) when required (estimated at 25%, might increase based on business needs).Role can be remote or based at any Lilly site/affiliate, corporate headquarters. Preference is at a Lilly site/affiliate or headquarters.