• Own and deliver BAU compliance support across IE-regulated entities, including activities subject to CASP and EMI requirements, and relevant conduct and market integrity considerations • Maintain and enhance the IE-regulated entities compliance framework (policies, procedures, governance materials, reporting calendar) to reflect business changes and IE regulatory expectations • Act as a trusted partner to Product, Design, Engineering and Markets teams to assist them to structure and launch products and services and controls • Lead and execute assurance monitoring and testing (risk-based), document findings clearly, and drive pragmatic remediation with accountable owners and timelines • Support regulatory engagement, including responses to information requests, examinations/audits, and routine/periodic reporting obligations where relevant • Review and advise on customer-facing communications and marketing for compliance risk and conduct considerations • Produce reliable management information for senior stakeholders (KRIs, monitoring outcomes, remediation progress, training completion) and assist in preparing reports for Committee and Board meetings on compliance related matters • Provide guidance and monitor outsourced compliance functions (e.g. marketing/complaints) to ensure compliance with CBI/EBA outsourcing guidelines and relevant requirements under MiCA/PSD2/CPC • Develop and deliver compliance training programs, ensuring employees are knowledgeable and aware of their obligations • Provide compliance advisory support and guidance to COs and EU Regional Compliance team on new and existing regulations and rules, best practices and compliance with internal procedures and directives • Ensure all Policies and Procedures are updated and submitted through appropriate governance forums • Contribute to a culture of compliance through training, clear guidance, and practical partnership with the business

• Advancing the execution of the Global Quality vision, policies, processes, and decisions • Collaborate with stakeholders to identify, communicate, and mitigate compliance risks • Continually enhance partnerships with key stakeholders and leaders across the business • Support and drive the implementation of quality and compliance projects and objectives • Stay updated on regulations and recommend proactive compliance changes when necessary • Execute against GVP Compliance processes and best practices • Perform GVP audits and contribute to the effective implementation of the Global GVP Audit Program • Act as a GVP compliance core team member on regulatory inspection teams and support mock readiness activities • Provide insights to continually optimize the GVP Compliance Audit Program • Contribute to Pharmacovigilance System Master File (PSMF) updates • Contributor to the Risk Evaluation and Mitigation Strategies (REMS) compliance program • Contribute to building a team that ensures GVP compliance and foster a culture of teamwork and mutual respect • Mentor and support the development of junior staff to achieve their full potential

• Act independently to lead global regulatory strategies for assigned products/indications through all phases of development to include regulatory approvals/product launches, and post-marketing efforts, with little to no oversight. • Will represent Regulatory Affairs as relates to development collaborations and/or partnerships, to include leading due diligence as required supporting BD activities • For new indications assigned, will lead effort on behalf of regulatory cross-functionally with colleagues from clinical, biostatistics, commercial, medical affairs, clinical pharmacology, safety, and others. Expected to provide material (content) input into potential study synopses and corresponding global regulatory briefing documents. • Continually expands TA knowledge and ensures strategic messaging and content of global regulatory dossiers, to include development of tumor landscape assessment to inform evolving development strategy. • Advises management and cross-functional team members of the effect of current or proposed relevant laws, regulations, guidelines, and standards, etc. • Key internal leader and driver of regulatory policy and strategy for assigned products • Lead regulatory team in the preparation and maintenance of risk assessment and mitigation strategy development for assigned products • Lead labeling strategy for given product(s)/indication(s), in support of initial license applications through post-marketing • Demonstrates excellent understanding of drug development and leadership behaviors consistent with the level • Accountable for ensuring that corporate goals are met with respect to assigned projects • Based on experience and scientific strengths, expands TA knowledge of TA; provides coaching and mentoring for other regulatory members and extra-departmental colleagues • Will have direct reports and contributes to the performance management for other RA team members • May advance the organization's goals by participating and taking leadership roles in professional associations, industry, and trade groups as appropriate • Follows budget allocations

• Responsible to lead regulatory strategy development and execution of pipeline assets for EEMEA region. • Supports country prioritization and effective product regulatory submission and approval in a seamless manner through to launch. • Develops regional/country regulatory strategies for new products filings and Life Cycle Management (LCM) activities (i.e.: new indications, major variations) aligning priorities with business objectives , local regulatory affairs teams and all relevant regional/global stakeholders/governance committees. • Assigned to key pipeline programs, ideally, as of Ph IIa (Proof of Concept, PoC) through to last country launch in region. • Serves as single Point of Contact (POC) for specific products for country regulatory teams /HQ teams/regional stakeholders, including Business, Market Access, Medical, etc. • Stays updated on our company's pipeline filings, relevant regional and local regulations and guidelines, collects relevant regulatory information (regulatory intelligence) for the region and keeps relevant stakeholders appropriately informed. • Responsible to lead development of the HA responses in collaboration with the response team, for new products filings and Life Cycle Management (LCM) activities (i.e.: new indications, major variations). • Works with all stakeholders to ensure seamless planning and execution, according to the prioritization, resulting in high quality and compliant on-target regulatory submissions, managing the Health Authority questions, on time approvals, and successful launches. • Provides support for New Indications and/or Major Variations that impact launch. • Leads/Contributes and represent the Region for regional/global projects. Identifies any internal process and/or communication gaps, resolves these or escalates these to regional and global stakeholders for resolution.