Tonya mc Clendon
Sr Manager Regulatory Operations @Xeris Pharmaceuticals, Inc.
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WORK HISTORY
Sr Manager Regulatory Operations @Xeris Pharmaceuticals, Inc.
Chicago, IL, US
Overseeing the company’s regulatory operations function and ensuring that regulatory information systems align with organizational goals. Driving cross-functional regulatory initiatives and fostering collaborative relationships across departments.· Ensuring submission archives and lifecycle documentation are maintained according to company standards and regulatory requirements.· Leading continuous improvement initiatives in regulatory operations, including SOP development and training.· Managing Regulatory Submission Tracker by identifying and resolving issues affecting submission timelines; driving process efficiency and ensuring high-quality, timely submissions.· Regulatory Intelligence - monitoring global regulatory policies, guidance, legislation, and agency announcements that impact the company’s product portfolio.· Maintaining a centralized repository for regulatory intelligence, including updates, timelines, and impact assessments.· Developing, reviewing, and managing contracts and service agreements with regulatory consultants, vendors, and third-party partners.· Supporting vendor sourcing, RFP processes, and contract negotiations to secure cost-effective regulatory services.· Collaborating with Finance and Legal teams to ensure timely contract execution, budget reconciliation, and invoice processing.· Leading, planning, tracking, and forecasting of budgets for regulatory activities.· Tracking regulatory project costs, milestones, and invoicing; flag variances and recommend corrective actions.· Maintaining internal systems to organize agreements, budgets, and correspondence.· Leading the review and maintenance of labeling content for new products, line extensions, and label updates.
EDUCATION
Carmel Catholic High School
College/University Preparatory, High School/Secondary Diploma Programs
Columbia College
Master of Business Administration (M.B.A.), Business Management
Columbia College
Bachelor of Science (BS), Business Administration: Management and HR Management
SKILLS
ABOUT TONYA MC CLENDON
Strategic regulatory affairs leader with deep expertise in regulatory compliance, submissions, documentation, and FDA reporting within healthcare and pharmaceutical industries. Brings extensive experience driving regulatory strategy, leading cross-functional teams, and managing complex projects from development through approval. Proven track record of leadership in high-stakes environments with focus on accuracy, efficiency, and compliance. Holds an MBA in Business Management and certifications in Problem Solving and Business Strategy, blending regulatory depth with strategic business acumen to support organizational growth and innovation.Business Administration,| Business Process Improvement | Communication | Regulatory Compliance | Databases | Confidentiality | Cost Reduction | Document Management Systems |Documentum | Electronic Common Technical Document | Expense Management Technical Skills ISIWriter, ISIToolbox, eCTDXpress, IBM Score, and eCTDManager Certified.
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