Rakuten Medical

Compliance

• 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.

Director/Senior Director of Global Regulatory Affairs