• The Director, CDx Regulatory Consultant will be responsible for applying deep expertise in companion diagnostic regulatory strategy, IVD development, quality system expectations, and global marketing authorization pathways to advise pharmaceutical, biotechnology, and diagnostic clients on the development, clinical trial use, approval, and lifecycle management of companion diagnostics. • Translate complex FDA, EU IVDR, and other global regulatory requirements into practical, actionable strategies that support Rx Dx co-development, patient selection assays, analytical and clinical validation planning, clinical trial enabling submissions, and coordinated diagnostic and therapeutic commercialization. • Serve as the CDx regulatory subject matter expert for strategic positioning of client programs. • Proactively identify client needs by understanding the therapeutic program, biomarker strategy, intended use population, assay technology, clinical trial design, and commercial objectives. • Lead consulting engagements with pharmaceutical clients to develop global CDx regulatory strategies, integrated development roadmaps, submission pathways, and milestone-based timelines that support clinical trial execution, regulatory authorization, and commercialization objectives. • Partner cross-functionally with therapeutic development teams, diagnostic manufacturers, laboratories, biostatistics, clinical operations, quality assurance, and commercial stakeholders to ensure CDx development activities are coordinated with overall program timelines and regulatory expectations.

• Own the ongoing review and maintenance of organizational security policies, standards, and procedures. Assist in identifying policy gaps based on evolving regulatory requirements, business needs, and industry best practices. • Serve as a primary cross-functional coordinator with other dedicated compliance teams (e.g., Legal, Regulatory Affairs, Internal Audit) to design and maintain a unified, strategic governance roadmap that ensures all corporate compliance activities are aligned, documented, and consistently executed across the enterprise. • Lead security risk assessments for new and renewing third-party vendors third-party vendors as part of the procurement lifecycle. Track remediation items and collaborate with stakeholders to address identified risks. • Coordinate and support the organization's annual security audits and certifications (e.g., SOC 2, PCI, CIS). Coordinate evidence collection, track action items, communicate with stakeholders, and assist with audit readiness activities. Lead cross-functional coordination with internal SMEs to support evidence collection activities with internal SMEs to support the internal evidence gathering process across multiple departments, reviewing appropriateness, tracking action items, and ensuring timely submission of required documentation. • Assist with the administration and continuous improvement of the company’s security awareness and training program, including tracking completion metrics and updating training content as needed. • Work in close partnership with Legal and Regulatory teams to interpret new and changing compliance requirements. Provide security insight to ensure corporate practices and technology align with legal and regulatory mandates. • Proactively identify and drive improvements to the efficiency, consistency, and scalability of GRC processes of GRC processes and documentation. Contribute to initiatives that enhance operational maturity and reduce organizational risk. Ensuring internal tools and processes meet control objectives and reduce organizational risk. • Maintain and help evolve risk and issues registries, tracking exceptions, risk owners, update timelines, and supporting broader risk management initiatives across Security and IT functions.

• Assist with the coordination of translation of regulatory correspondence and submission documents such as protocols, synopsis, ICF and labels • Pack and dispatch regulatory submissions, site contracts, and site documents, follow up for delivery confirmation, obtain and file acknowledgement receipts and update relevant tracking tools • Perform administrative QC of regulatory submissions, site documents and site contracts to ensure correct completeness and formatting • Liaise with Finance requesting fee payment to Regulatory Authorities. Closely monitor the assigned Therapeutic mailbox and triage requests to the correct team members for prompt action

• Liaise with SAR colleagues to drive plan, organize, compile, progress, track, and submit regulatory submissions on a timely basis and with a consistently high level of quality. • May act as a contact point for translation review of submission documents such as applications, synopses, ICFs, labels, etc. • Maintain country-specific patient information sheet and consent form customization text. • Maintain country-specific drug labeling information and Country Intelligence Pages. • Review and make recommendations on all relevant documentation e.g. labels, patient information sheets, diary cards etc. to comply with ICH GCP & country-specific requirements.