Regulatory Affairs Sr. Associate

　　The Sr. Associate, Regulatory Affairs position supports the Regulatory Manager as part of the QA/RA Department by maintaining product compliance.

　　Key Responsibilities- The core elements of Controlled Substance Monitoring Program (CSMP) Include:

　　Conducting/Maintaining due-diligence and reviewing SAP, forms, and processesReviewing prospective Customers and determining whether a prospective Customer may be approved to receive controlled substances distributed by RxCReviewing Customers on an ongoing basis and, as appropriate, determining when a customer is no longer approved to receive controlled substances distributed by RxCEstablishing and maintaining order thresholds for approved Customers that limit the monthly quantity of controlled substances for each base code that Customers may orderMonitoring Customer's orders for controlled substances to identify orders of interest in accordance with certain specified criteriaInvestigating each order of interest and documenting RxC's determination as to the disposition of the order, including whether to release or block the orderReporting to DEA and relevant state regulatory authority's orders blocked under the CSMP as suspicious ordersMaintaining Import/Export documentsEnsuring FDA Readiness documents are complete and accurateProduct VerificationEnsuring DSCSA adherence and complianceCoordinates and conducts the assessment of internal controls to ensure compliance as required by regulatory commissions/authoritiesManages complaint cases brought to regulatory authorities and process improvements to avoid future complaintsAdvances organization positions with internal and external partiesPrepares and sponsors testimony to governmental or regulatory agenciesDocuments internal regulatory processes, such as internal audits, inspections, license renewals, or registrationsPrepare materials for submission to regulatory agenciesConduct employee regulatory trainingInterprets regulatory rules or rule changes and ensure that they are communicatedMaintains current knowledge base of existing and emerging regulations, standards, or guidance documentsTracks quality regulatory metricsParticipates in internal or external auditsMaintains technical files as necessary to obtain and sustain product approvalAny other duties as assigned.

　　Minimum Requirements:

　　High School degree or equivalent2+ years of relevant experience

　　Business Experience:

　　Knowledge of all regulatory aspects of business Ability to communicate both verbally and via documentationHighly MotivatedDetail OrientedExcellent Problem-Solving SkillsStrong Work Ethic/DependabilityProfessional in behavior and appearanceBe able to work independently or with a cross team effortAnalytical mindComputer knowledge, fluent in Microsoft Office and Excel but able to learn other programs easily Specialized Knowledge/SkillsFamiliarity with CFRs, cGMPs and GDPsAction OrientedDrive for ResultsAdaptabilityTechnology adaptiveStrong writing skillsAbility to lead intradepartmental groups and multiple teams

　　Working Conditions:

　　Traditional office environment.WarehouseTravel: Less than 10%

　　Physical Requirements:

　　Large percent of time performing computer-based work is required

　　At CoverMyMeds, we care about the well-being of the patients and communities we serve, and that starts with caring for our people. That's why we have a Total Rewards package that includes comprehensive benefits to supportphysical, mental, and financial well-being. Our Total Rewards offerings serve the different needs of our diverse employee population and ensure they are the healthiest versions of themselves. For more information regarding benefits at CoverMyMeds, please

　　As part of Total Rewards, we are proud to offer a competitive compensation package at CoverMyMeds. This is determined by several factors, including performance, experience and skills, equity, regular job market evaluations, and geographical markets. In addition to base pay, other compensation, such as an annual bonus or long-term incentive opportunities may be offered.

　　Our Base Pay Range for this position

　　$57,900 - $96,500

　　CoverMyMeds is an equal opportunity and affirmative action employer. We embrace diversity and are committed to creating an inclusive environment for all employees.Qualified applicants will be considered for employment without regard to r ace, r eligion, gender, gender identity, s exual orientation, national origin, age, disability or veteran status.

　　McKesson is an equal opportunity and affirmative action employer - minorities/females/veterans/persons with disabilities.