- Lead global regulatory submission strategies across the FDA, EU, China, and Japan.
- Manage dossier preparation, compilation, and submission activities to meet regulatory requirements and timelines.
- Coordinate external service providers and publishing vendors to support dossier delivery and submissions.
- Identify submission risks, address resource constraints, and support problem-solving to maintain project timelines.
- Drive submission activities across the product lifecycle, from First-in-Human studies through license withdrawal.
- Partner with Global and Regional Regulatory Leads and cross-functional teams on regulatory roadmaps.
- Build and maintain project management tools, submission schedules, dashboards, and milestone tracking.
- Oversee reference dossier preparation for Modules 2–5 and alignment with global and local requirements.
- Monitor submission progress, manage dossier updates, coordinate responses to health authority questions, and maintain regulatory database compliance.
Project Management