• Develop and execute integrated regulatory strategies that optimize approval pathways for drug and device across all regions where clinical studies are conducted. • Lead cross-functional teams to prepare high-quality regulatory submissions. • Ensure compliance with all applicable global laws, regulations, and standards (eg FDA CFR, EMA guidelines, ICH, PMDA standards, EU MDR/IVDR, GCC regulations). • Develop regulatory project plans and timelines; coordinate submission team and regulatory department meetings. • Work closely with teams in CMC, nonclinical, clinical development, medical writing, safety/PV, quality assurance, medical affairs, and program management to support timely and compliant submissions. • Monitor regulatory commitments, deliverables, and submission content across regions.