• Supporting the Executive Director in leading enterprise wide quality compliance, governance, operational process excellence, vendor governance and risk management functions across Parexel’s global Data & Technology (D&T) organisation. • Providing strategic and operational oversight for governance frameworks, Quality Management System (QMS) alignment, SDLC governance, supplier oversight, risk management and compliance by design practices supporting regulated and non-regulated technology environments. • Serving as a senior leader responsible for strengthening operational discipline, inspection readiness, regulatory confidence and enterprise governance maturity while enabling modern, scalable and agile technology delivery. • Supporting enterprise audit, regulatory inspection readiness, inspection coordination, audit responses and remediation activities. • Owning and continuously improving QMS processes, SOP governance, controlled document lifecycle management and associated standards, templates and work instructions. • Supporting enterprise SDLC governance, change management, release management and operational control processes across the technology lifecycle. • Driving standardization, harmonization, process simplification and compliance by design across governance and delivery processes. • Leading vendor qualification, governance, oversight and risk management for suppliers, cloud providers, strategic technology partners and outsourced delivery teams. • Defining and maintaining supplier governance strategies, technical agreements, service expectations, performance monitoring and risk frameworks aligned to regulatory and operational expectations. • Developing, maintaining and continuously improving D&T quality and operational risk frameworks, including criteria, tolerance, appetite, dashboards and executive-level reporting. • Leading proactive risk identification, escalation, mitigation, governance assessment and continuous improvement activities across regulated technology environments. • Acting as a key member of the Quality Leadership Team and partnering closely with D&T, Quality, Regulatory, Clinical, Security and Operational stakeholders.

• Facilitate product development and global registration by developing and executing regulatory strategies • Manage effective regulatory agency interactions for product manufacturing and quality programs throughout product lifecycle • Contribute as a member of the global regulatory CMC product team • Interact with authors/reviewers and subject matter experts with respect to delivery of regulatory documents required for regulatory submissions • Contribute to the organization and preparation of CMC investigational product amendments, post-market supplements/variations, and new marketing applications • Document and archive CMC submissions and related communications in the document management system • Initiate and maintain CMC product timelines at the direction of product lead • Interface with the regulatory operations team • Train staff on select CMC procedures and systems • Provide report status of activities and projects to teams and department • Participate in cross-functional special project teams

• Execute U.S. regulatory strategy and deliverables for assigned programs and represent the region on global teams (e.g., GRT; may include GDT/CST/LWG as applicable). • Plan and manage U.S. regulatory submissions (e.g., clinical trial and marketing applications) aligned with global filing plans and U.S. regulatory requirements. • Implement product-related regulatory tactics and activity plans in accordance with U.S. legislation, regulations, and internal standards. • Provide content guidance for key U.S. regulatory documents and meetings consistent with GRT strategy (e.g., briefing content, submission components). • Support U.S. labeling development in collaboration with the Labeling Working Group (LWG), incorporating scientific data, guidance, and precedent; support U.S. labeling negotiation activities. • Provide regulatory guidance on U.S. mechanisms and pathways to optimize development (e.g., expedited programs, orphan considerations, pediatric plans, compassionate use where applicable). • Obtain and maintain clinical trial authorizations and marketing application approvals, including support for Responses to Questions (RTQs) and other agency feedback. • Communicate regulatory strategy and expectations within the team (e.g., GRT, affiliates/stakeholders) and work with line management to assess likelihood of success, expectations, and risks. • Ensure ongoing regulatory compliance for assigned products (e.g., IMR accuracy, PMCs/commitments, pediatric and other agency obligations); escalate issues proactively. • Maintain and apply U.S. regulatory intelligence: monitor evolving legislation/guidance; research precedent and history; assess and communicate potential impact (including competitor labeling where relevant). • Support Health Authority interactions by acting as an agency contact as appropriate, documenting outcomes, and contributing to risk/contingency planning consistent with global strategy. • Partner with cross-functional teams to support alignment and execution, including U.S.-specific considerations for data use in product communications (as applicable).

• Support products in the Obesity and Related Conditions Therapeutic Area • Develop and execute regulatory strategy in close partnership with the Global Regulatory Lead (GRL) • Represent the U.S. on global teams and contribute to global regulatory and clinical development strategies • Plan and lead U.S. regulatory submissions in alignment with global filing plans and regulatory requirements • Lead development of key regulatory documents, including labels, briefing packages, and submission components aligned with product strategy • Drive U.S. labeling strategy and execution in collaboration with the Labeling Working Group • Lead Health Authority interactions for assigned products • Assess regulatory risk and likelihood of success; communicate scenarios and contingencies to the GRL, GRT, and senior management. • Ensure ongoing compliance for assigned products and proactively escalate issues