Senior Regulatory

OverviewAs a Senior Regulatory Affairs Associate, you will drive post-approval regulatory activities focused on CMC for biological and vaccine products. You will collaborate across manufacturing, QA, QC, and regulatory teams to shape submission strategies and ensure worldwide compliance. Your work supports variations, renewals, and market expansions,...

OverviewIn this senior regulatory role, you provide strategic legal guidance across the lifecycle of Illumina's medical devices, diagnostics, and life-science products in EMEA and Latin America. You collaborate with cross-functional teams to enable compliant product development, submission, and post-market activities in a fast-paced, international setting....

OverviewIn this role you will lead labeling strategy within Global Regulatory Affairs to align CCDS, dCCDS, USPI and EU SmPC across products. You will influence product development plans, ensure compliant labeling and support commercial opportunities. You'll collaborate with GRA, GCD, GCSP and cross-functional teams to maintain global consistency and...

OverviewAs Senior Global Patient Safety Physician at Chiesi, you lead safety science for assigned products, shaping proactive risk management and safety surveillance. You collaborate across Clinical Development, Medical Affairs, Regulatory, Quality and external partners to integrate safety data into development plans and submissions. You drive science-led...

OverviewAs Senior Process Scientist, you will drive the development and manufacturing oversight of LNP-based gene therapy programs within Chiesi Global Rare Diseases. You'll lead formulation development, screening, and process optimization, partnering with external CROs/CDMOs and internal CMC teams to advance candidates from discovery through clinical...

OverviewIn this role you steer the global clinical development strategy for key respiratory indications, leading a physician-scientist team across geographies. You will align R&D and commercial goals, shape trial designs, and drive regulatory success with high scientific and operational impact. You thrive in a cross-functional, matrix environment and help...

OverviewIn this role you will provide strategic legal support for European R&D activities and select markets, partnering with regional and global teams to navigate clinical trials, regulatory, data privacy, and vendor relations. You will translate complex regulations into practical risk mitigations while supporting global programs across diverse...

OverviewIn this role you will lead Group-level oversight of regulatory credit risk models (IRB and IFRS 9), advising senior Risk Management and Model Development teams while applying independent technical judgment on model risk and supervisory expectations. You will coordinate changes, reviews and governance with internal stakeholders and external...

As Statistical Scientist Director, you will lead statistical strategy for complex client studies, guiding design through reporting. You will translate quantitative concepts for non-statistical stakeholders and oversee innovative analysis approaches. You’ll manage deliverables, risk mitigation, and regulatory alignment, while supporting business development...