Manager, Regulatory & Clinical Affairs

The Manager, Regulatory & Clinical Affairs, plays a key role in ensuring regulatory compliance and labeling accuracy across all Quva sites. This role oversees third party submissions, supports product formulation, conducts therapeutic equivalency reviews, and manages the development of CSP and Bulk artwork. The Manager also coordinates investigations, supports customer onboarding through ASHP tool assessments, and partners with cross-functional teams to align regulatory and clinical activities with business goals, all while maintaining compliance with FDA 503B requirements. At Quva, you will be an essential part of a mission-driven organization dedicated to expanding critical access to quality, affordable medication and data insights while promoting a culture of innovation, collaboration, and continuous improvement. What the Manager, Regulatory & Clinical Affairs Does Each Day:Oversee third party submissions (First Data Bank, Medi-Span, Cerner Multum, IBM/Redbook)Review and approve the accuracy of label claims for new artwork creation and bulk labels to ensure alignment with FDA 503B labeling requirementsSpearhead the development and regulatory oversight of CSP and bulk artwork across all QuVa sites to ensure consistency and compliance.Review and approve therapeutic equivalency for product conversionDrive team improvements by resolving inefficiencies and implementing sustainable, safety focused solutionsManage change requests for BUD extension in collaboration with Quality ControlReview and approve REMSSupport staff with pharmaceutical calculations, product formulations, and related labeling inquiriesServe as a backup for Master Batch Records, Bill of Materials as neededStrengthen team performance through workforce planning, development, and leadership growth initiativesWork with cross-functional teams to align Regulatory & Clinical Affairs activities with overall business objectivesCoordinate investigations of deviations and CAPAs owned by Pharmacy ServicesManage ASHP tool assessment questionnaires and support customer onboardingCollaborate on vendor contract questionnaires for new customers and renewalsEvaluate Finished Drug Product to ensure label compatibility and complianceAssist with FDA inspections related to labeling and ensure compliance with 503B requirementsCreate and update SOPs as applicableMaintain a safe and clean working environment by complying with procedures, rules, and regulationsOur Most Successful Manager, Clinical & Regulatory Affairs has / is:Sense of urgency, accountability and resourcefulness (e.g., work in changing environment)Self-starter, independent learnerCommunication: Promotes active listening with team members; Contributes appropriately to conversations; Strong verbal and written communication skills with the ability to work effectively with other departments within the organization and with people at all levels of the organizationProblem Solving: Understands how various issues affect each other and the outcome of projects; Improves upon existing approaches by seeking opportunities to creatively transformEfficiency with MS Office suiteMinimum Requirements for this Role:Legally authorized to work in the job posting countryBachelor’s Degree required5-7 years in an FDA cGMP environment with 3+ years in a supervisory roleQuality or Pharmacy experienceKnowledgeable in FDA cGMP complianceMust have hospital pharmacy experienceBenefits of Working at Quva:Comprehensive health and wellness benefits including medical, dental and vision401k retirement program with company match22 paid days off plus 8 paid holidays per yearNational, industry-leading high growth company with future career advancement opportunitiesAbout Quva:Quva provides industry-leading health-system pharmacy services and solutions, including 503B sterile injectable outsourcing services and AI-based data software solutions that help power the business of pharmacy. Quva Pharma’s multiple production facilities and industry-first dedicated remote distribution capabilities provide ready-to-administer sterile injectable medicines critical to patient care. Quva BrightStream partners with health systems to aggregate, normalize, and analyze large amounts of complex data across their sites of care, and through proprietary machine learning, transforms data into actionable insights supporting revenue optimization, script capture, inventory management, drug shortage control, and more. Quva’s overall progressive and integrated platform helps health-systems transform pharmacy management to achieve greater value and deliver highest-quality patient care.Quva is an equal opportunity employer and is committed to creating and maintaining a work environment that is free from all forms of discrimination and harassment. Quva's Equal Opportunity Policy prohibits harassment or discrimination due to age, ancestry, color, disability, gender, gender expression, gender identity, genetic information, marital status, medical condition, military or veteran status, national origin, race, religious creed, sex (including pregnancy, childbirth, breastfeeding, and any related medical conditions), sexual orientation, and any other characteristic or classification protected by applicable laws. All employment with Quva is “at will.”California Consumer Privacy Act (CCPA) Notice for Applicants and EmployeesJob SummaryRequisition Number: MANAG006063Job Category: 3000-Pharmacy Services RDSchedule: Full-Time