Jobs at CSL

Leads global regulatory affairs activities, securing permits, licenses, certificates, authorizations, and approvals for business operations and product distribution. Advises management on regulatory developments, manages regulatory plans and documentation, maintains regulatory systems, and represents the organization before government and industry authorities. Requires pharmaceutical regulatory experience, with biologics experience preferred.

Drafts, reviews, and negotiates commercial agreements throughout the contracting lifecycle. Maintains contract templates, FAQs, and CLM records; advises business partners on legal matters; delivers training; and identifies opportunities to improve legal service efficiency through process optimization, automation, legal design, and technology. The role collaborates across departments and may require occasional domestic or international travel.

Leads CSL Behring’s state government affairs strategy across the Southeast US. Builds relationships with legislators, regulators, patient advocates, trade associations, and consultants; analyzes legislation and policy; advocates for Medicaid access and plasma donation; develops coalitions and action plans; represents company operations; and communicates policy insights to leadership and cross-functional teams.

Develop global regulatory CMC strategies for biologics and plasma-derived therapies. Lead digital innovation, regulatory intelligence, submission management, outsourcing governance, KPI monitoring, policy development, SOP implementation, inspection support, and due diligence. Coordinate cross-functional and external stakeholders across global geographies, interpret FDA, EMA, PMDA, and NMPA regulations, advise senior leaders, and support compliant product development, registration, and lifecycle management.

Plan and manage clinical trial supplies for low-to-medium complexity studies: forecast drug volumes, collect/analyze samples, ensure storage/transport/archiving, manage vendors, use IRT, author/review study documents, lead global CTS meetings, partner with R&D, and update SOPs for continuous improvement and compliance.

Leads global intellectual property strategy for early research and development programs, including recombinant proteins, antibodies, plasma proteins, mRNA, gene and cell therapies, and other modalities. Manages patent attorneys and external counsel; oversees invention harvesting, patent prosecution, defense, enforcement, trade secrets, freedom-to-operate analysis, due diligence, transactions, litigation support, governance participation, budget planning, and strategic IP advice to senior R&D and research leadership.

Lead people-analytics strategy for Talent Acquisition and Talent Development. Drive end-to-end analysis of complex workforce problems, deliver evidence-based recommendations to senior leaders, ensure data governance and quality, coach junior analysts, build metrics frameworks, and conduct benchmarking and external research to inform workforce strategy.

Lead governance, review, and validation of clinical data deliverables ensuring CDISC/SDTM compliance and submission readiness. Oversee EDC/eCRF design, data quality control frameworks, vendor deliverable review, reporting/visualization, and integration of external data sources. Support scalable data platforms, automation, and AI-enabled capabilities while partnering with Data Management, Statistics, and vendors to ensure data traceability and regulatory alignment.

Manage end-to-end R&D contract administration and business operations, including drafting templates, executing contracts, vendor setup, PO creation, invoice resolution, recordkeeping, audits, stakeholder liaison with Procurement and Compliance, and supporting operational tracking and reporting.

Lead global IT sourcing strategy and a multi-year technology modernization agenda. Manage $450M spend, strategic supplier relationships, governance, risk, and value delivery. Oversee category management (cloud, software, infrastructure, cyber), negotiations with hyperscalers and SaaS vendors, stakeholder engagement, and build a high-performing sourcing organization.

Lead and execute nonclinical due diligence for in-licensing, acquisitions, and collaborations. Integrate toxicology, PK/QSP, and pharmacology data to assess translational risks, identify FIH-enabling gaps, and propose mitigations. Produce DD reports and executive summaries, advise Business Development and Therapeutic Area teams, maintain DD frameworks, mentor junior staff, chair the NCD Review Committee, and escalate high‑impact issues to leadership.

Lead global vaccines safety science activities including pharmacovigilance governance, regulatory compliance, signal detection, safety data analysis, inspection readiness, PSMF maintenance, process optimization, and technical translation of business requirements into reporting and visualization solutions. Manage teams, contribute to post-marketing and study safety reporting, and support regulatory submissions and audits.

Leads global technology sourcing strategies across software, SaaS, cloud, infrastructure, hardware, telecommunications, cybersecurity, and related services. Manages high-value competitive sourcing, negotiations, contracts, supplier relationships, risk mitigation, stakeholder alignment, and procurement transformation. Analyzes spend and market trends to deliver savings and value while ensuring governance, compliance, continuity, and supplier performance. Provides strategic guidance to sourcing managers and engages senior leaders and global technology suppliers.

Leads CSL’s global knowledge management and insight advisory service, overseeing strategy, governance, budgets, personnel, vendors, systems, data standards, and information resources. The role advances AI-focused digital innovation, manages research databases and APIs, supports scientific and regulatory information access, develops performance metrics, and leads global teams through coaching and collaboration. It requires extensive pharmaceutical, knowledge management, data governance, vendor management, and people leadership experience.

Leads global enterprise security for offices, laboratories, facilities, employees, contractors, and visitors. Manages physical security, risk assessments, crisis response, workplace violence prevention, investigations, access control, security training, contract security personnel, compliance, and incident management. Develops security strategies, policies, performance metrics, budgets, and corrective actions while briefing senior leadership and coordinating with law enforcement and regulatory agencies. The role requires 24/7 availability and domestic and international travel.

Leads technology platform strategy, delivery coordination, operational planning, complex projects, service improvements, and adoption initiatives. Partners with business, IT, architecture, vendors, and global stakeholders to maintain secure, compliant, scalable, and reliable platforms. Oversees roadmaps, governance, performance, risk, regulatory compliance, SDLC adherence, validation, data governance, and audit readiness while translating business needs into sustainable technology solutions.

Lead development and coordination of global regulatory CMC strategies for CAPEX, compliance, and outsourcing. Support digital innovation (including AI/ML), manage vendor relationships, monitor global regulations, advise senior leadership on regulatory implications, and implement regulatory policies, SOPs, and KPIs to drive operational alignment across Global Regulatory Affairs, R&D, Quality, and Global Operations.

Provide legal counsel and contract drafting/negotiation for global clinical development, advise on regulatory issues (GCP/ICH, FDA), escalate complex matters, create templates, deliver training, and support cross-functional global projects.

Lead establishment and maintenance of Portfolio Development processes, SOPs, training, and change initiatives. Drive process improvement, cross-functional programs, and procedural compliance to support clinical trial planning, evaluation, and reporting across global teams.

Lead regional enterprise contracting for the Americas, build stakeholder and external partner relationships, lead negotiations, improve contracting processes, manage risk and compliance, and drive legal technology and continuous improvement initiatives.