Compliance

• Take charge of planning, drafting, and submitting global regulatory filings including INDs, NDAs, CTAs, MAAs, and pediatric development plansowning everything from original submissions to post-approval documentation.
• Lead cross-functional teams spanning nonclinical, clinical, CMC, stats, and operations, pushing programs forward while meeting tight timelines and quality expectations.
• Drive strategic and hands-on regulatory operations throughout the product lifecyclefrom first-in-human to commercialization.
• Partner with clinical and safety teams to manage labeling, risk mitigation strategies, pharmacovigilance requirements, and lifecycle management.
• Interface directly with regulatory bodies (FDA, EMA, and others) and confidently lead agency meetings, teleconferences, and written communications.
• Evaluate and implement fast-track mechanisms, adaptive design approaches, and other accelerated regulatory pathways to compress development timelines.
• Ensure internal teams and external partners are aligned and equipped to meet regulatory milestones on time.
• Oversee external regulatory writers and consultants, balancing internal ownership with outsourced support.
• Maintain sharp awareness of global regulatory shiftsincluding FDA, EMA, and evolving EU regulationsand translate that into forward-looking action.

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