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More>Coco Panda
Focus on administrative law, healthcare regulation, and risk management.
Strong foundation in life sciences supporting regulatory strategy and product submissions.
Regulatory Affairs leader with 12+ years of experience guiding FDA, global compliance, and product lifecycle strategy for highly regulated healthcare organizations. Proven record leading submissions, inspections, labeling governance, and cross-functional risk mitigation that supports market access and business growth. Trusted partner to legal, quality, clinical, and executive stakeholders.
Recognized by executive leadership for building a cross-functional regulatory governance model that improved submission readiness and decision transparency across four business units.
Led regulatory due diligence for two strategic acquisitions, identifying material compliance risks early and supporting integration plans that protected launch timelines.
Developed a board-level regulatory risk dashboard adopted for quarterly reporting, strengthening oversight of enforcement exposure, inspection trends, and remediation progress.
- Directed regulatory strategy for specialty therapeutics portfolio, leading U.S. and ex-U.S. submissions that achieved 100% on-time filing performance across 14 major regulatory milestones.
- Managed FDA meeting preparation, briefing documents, and response strategies, contributing to successful resolution of 92% of agency information requests within committed timelines.
- Partnered with legal, quality, and clinical leaders to strengthen labeling and promotional review controls, reducing compliance deviations by 38% over two audit cycles.
- Built and coached a team of 8 regulatory professionals, improving submission quality, succession depth, and stakeholder satisfaction scores across development and commercial functions.
- Led inspection readiness planning and remediation governance, closing 27 regulatory action items within six months and maintaining inspection outcomes without critical observations.
- Oversaw 510(k), PMA supplement, and international registration activities for Class II and III devices, supporting product launches in the United States and five global markets.
- Coordinated cross-functional submission teams spanning R&D, quality, and manufacturing, shortening average dossier completion time by 21% through standardized planning templates and review checkpoints.
- Advised senior management on changing FDA guidance and enforcement trends, enabling proactive policy updates that reduced documentation gaps during internal compliance reviews.
- Authored and negotiated regulatory submissions, deficiency responses, and health authority correspondence, improving first-cycle acceptance rates from 78% to 91% within two years.
Coco Panda
Focus on administrative law, healthcare regulation, and risk management.
Strong foundation in life sciences supporting regulatory strategy and product submissions.
Regulatory Affairs leader with 12+ years of experience guiding FDA, global compliance, and product lifecycle strategy for highly regulated healthcare organizations. Proven record leading submissions, inspections, labeling governance, and cross-functional risk mitigation that supports market access and business growth. Trusted partner to legal, quality, clinical, and executive stakeholders.
Recognized by executive leadership for building a cross-functional regulatory governance model that improved submission readiness and decision transparency across four business units.
Led regulatory due diligence for two strategic acquisitions, identifying material compliance risks early and supporting integration plans that protected launch timelines.
Developed a board-level regulatory risk dashboard adopted for quarterly reporting, strengthening oversight of enforcement exposure, inspection trends, and remediation progress.
- Directed regulatory strategy for specialty therapeutics portfolio, leading U.S. and ex-U.S. submissions that achieved 100% on-time filing performance across 14 major regulatory milestones.
- Managed FDA meeting preparation, briefing documents, and response strategies, contributing to successful resolution of 92% of agency information requests within committed timelines.
- Partnered with legal, quality, and clinical leaders to strengthen labeling and promotional review controls, reducing compliance deviations by 38% over two audit cycles.
- Built and coached a team of 8 regulatory professionals, improving submission quality, succession depth, and stakeholder satisfaction scores across development and commercial functions.
- Led inspection readiness planning and remediation governance, closing 27 regulatory action items within six months and maintaining inspection outcomes without critical observations.
- Oversaw 510(k), PMA supplement, and international registration activities for Class II and III devices, supporting product launches in the United States and five global markets.
- Coordinated cross-functional submission teams spanning R&D, quality, and manufacturing, shortening average dossier completion time by 21% through standardized planning templates and review checkpoints.
- Advised senior management on changing FDA guidance and enforcement trends, enabling proactive policy updates that reduced documentation gaps during internal compliance reviews.
- Authored and negotiated regulatory submissions, deficiency responses, and health authority correspondence, improving first-cycle acceptance rates from 78% to 91% within two years.
