• Provide leadership and strategic oversight for DRA operations, setting standards for operational excellence, execution discipline, and departmental consistency. • Provide strong regulatory project management for critical cross-organizational initiatives including but not limited to M&A, site or portfolio changes. • Drive operational excellence across DRA by overseeing core processes, workflows, and documentation practices. • Lead process related activities, including continuous improvement, standardization, and deployment of tools, templates, and dashboards. • Develop, track, and report regulatory metrics and KPIs, providing insights that support data-driven decisions and operational transparency. • Serve as a strategic partner within DRA LT, helping translate priorities into actionable plans and coordinating planning cycles and long-range strategies. • Partner within DRA and with key cross functional stakeholders (i.e. Quality, R&D, Supply Chain, MSAT, Manufacturing, Program Management, and Commercial) to support planning, workload forecasting, prioritization, and lifecycle strategies. • Contribute to enterprise-level initiatives requiring DRA operational leadership or strategic input.

• Partner with Client Experience Teams to identify, assess, and address employee benefits compliance risks and support clients in developing practical compliance strategies. • Provide consultative guidance to clients and internal stakeholders on health and welfare compliance matters, including but not limited to ERISA, ACA, COBRA, HIPAA, Section 125, MHPAEA, and other applicable federal requirements. • Assist in conducting compliance reviews and assessments, and assist in the development of recommendations and corrective action strategies. • Research, analyze, and interpret legislative, regulatory, and administrative guidance impacting employer-sponsored benefit plans. • Monitor regulatory developments and emerging compliance trends and communicate relevant developments to clients and internal stakeholders in a timely manner. • Develop client-facing communications, alerts, presentations, training materials, and other educational resources regarding regulatory developments and compliance best practices. • Deliver presentations, webinars, and training sessions to clients, prospects, and internal colleagues. • Collaborate with internal subject matter experts, external legal counsel, compliance vendors, and carrier partners, as appropriate, to support client needs and ensure accurate guidance. • Serve as a key partner to senior Compliance leaders by supporting complex client engagements, regulatory initiatives, thought leadership efforts, and the ongoing development of the firm's compliance solutions and resources. • Contribute to the creation, maintenance, and enhancement of compliance tools, templates, assessments, and other resources used by clients and internal teams. • Support the Compliance team in maintaining consistent, practical, and client-focused guidance across the organization. • Demonstrate a commitment to continuous learning and professional development while contributing to a collaborative and high-performing team environment.

Role Description Zayo is seeking a dynamic and detail-oriented Government Compliance Specialist at the entry-to-mid level, dedicated to ensuring compliance with federal and state telecommunications regulations and orders. Our Government Compliance Specialist will monitor a broad spectrum of state and federal telecommunication rules and orders, develop and implement policies, respond to government inquiries, and manage Zayo’s reporting obligations. This position will work closely and collaboratively with Zayo’s business professionals with oversight and support of other members of Zayo’s legal team. This position reports directly to the General Counsel supporting state and federal sales. We are seeking a strong candidate ready to take on responsibility, learn through doing, and excited to take the next challenge in their career. - Monitor state and federal rules and orders to ensure compliance and informed decision-making. - Develop and implement policies and processes aligned to telecommunications regulatory obligations. - Draft documents for regulatory proceedings, including pleadings, comments, and interrogatories. - Respond to government inquiries, including federal and state audits and investigations. - Collaborate with tax, finance, and company-wide subject matter experts to generate and file periodic regulatory reports. - Develop and review customer communications. - Develop and conduct employee training for compliance with company regulatory policies. Qualifications - Bachelor’s degree, Master’s degree in business or a related field, or paralegal certificate required. - Experience in telecommunications regulatory compliance, legal research, and/or project management required. - Ability to work independently and remotely, demonstrating self-motivation and initiative. - Ability to communicate with other personnel and external parties through strong organized writing and verbal skills. - Strong attention to detail and organizational skills. - Experience with Microsoft Office suite including but not limited to Excel file management. Requirements - Estimated base salary range: $61,100 - $94,000 USD/annually. - The base pay range shown is a guideline and reasonable estimate for this role. - Actual compensation offered may vary from the posted range based upon geographic location, work experience, skill level, certifications, and other business and organizational needs. - Non-sales roles may be eligible to participate in a discretionary annual incentive plan. - Sales roles may be eligible to participate in a sales incentive plan. - This position may be eligible for certain benefits, such as health insurance, life insurance, disability retirement plans, paid time off. Benefits - Excellent Health, Dental & Vision Insurance - Retirement 401(k) Savings Plan - Generous paid time off policy including paid parental leave

Role Description The Regulatory Submission Coordinator – Associate/ Sr Associate level supports the execution and coordination of regulatory submission and labeling activities across assigned countries within a region. Reporting to the Regional Submission Coordinator (Lead), this role focuses on operational delivery, documentation coordination, system updates, and labeling execution to ensure timely, compliant, and high-quality regulatory submissions. The Associate works in close collaboration with the Lead, Regional Regulatory Leads (RRLs), Local Regulatory Responsible (LRRs), Regulatory Partner Representatives (RPRs), and cross-functional stakeholders. Key Responsibilities - Submission Coordination & Operational Support - Support the coordination, preparation, and delivery of regulatory submissions and lifecycle management (LCM) activities in accordance with submission strategies defined by the RRL and coordinated by the Regional Submission Coordinator (Lead). - Assist in organizing submission team meetings (e.g., Kick-off Meetings) and follow up on agreed actions. - Coordinate, request, and track documentation from Subject Matter Experts (SMEs) to support submission readiness and timelines. - Support the preparation and maintenance of the Submission Content Plan (SCP) under the guidance of the RSC Lead. - Ensure timely dispatch of non-eCTD submission packages to LRRs and RPRs and track dispatched documentation per country. - Labeling Operational Support - Provide hands-on operational support for labeling activities, performing assigned tasks under the guidance of the RSC Lead. - Prepare annotated labeling documents for regulatory review in collaboration with RRLs, LRRs, and RPRs. - Initiate and coordinate mock-up requests in the Artwork Management System. - Track print releases as required. - Support change control activities related to local labeling updates. - Ensure appropriate archiving of labeling documentation and that approved labeling is accurately and timely stored in DocNet. - Regulatory Systems & Documentation - Support the creation, maintenance, and accuracy of submission and regulatory records in regulatory systems (e.g., Veeva RIMS, Apollo). - Upload Module 1 and non-eCTD submission documents to DocNet and ensure completeness and traceability. - Update regulatory systems with Health Authority interactions, including uploading questions received from Health Authorities in the appropriate records. - Support data quality and consistency across systems and documentation repositories. - Project Support & Communication - Provide regular status updates to the Regional Submission Coordinator (Lead) on assigned activities, timelines, and potential issues. - Support tracking of submission milestones, deliverables, and dependencies. - Escalate operational issues or delays to the RSC Lead with appropriate context and proposed mitigation actions. - Collaborate effectively with cross-functional teams including CMC, labeling, quality, and regulatory stakeholders. - Quality & Compliance - Perform assigned activities in compliance with applicable SOPs, work instructions, and regional regulatory requirements. - Support inspection readiness by ensuring accurate, complete, and well-organized submission and labeling documentation. - Maintain awareness of regional regulatory processes relevant to assigned activities and follow guidance provided by the Lead and RRLs. Qualifications - Bachelor's degree in Life Sciences, Pharmacy, or a related discipline - Associate: 1–3 years of experience, Sr Associate +3 years in regulatory affairs, regulatory operations, or a related pharmaceutical/biotechnology role - Experience with Biological Products (Mandatory) - Good understanding of regulatory submission processes and lifecycle management activities - Experience with Veeva RIM and document management tools - Strong organizational skills with attention to detail and quality - Ability to manage multiple tasks and timelines in a matrix environment - Effective written and verbal communication skills in English and Spanish (mandatory) Equal Opportunity Statement Parexel is an Equal Opportunity Employer. We celebrate diversity and are committed to creating an inclusive environment for all employees. We do not discriminate on the basis of race, color, religion, sex, national origin, age, disability, veteran status, or any other legally protected characteristic.