Mannheim, Baden-Württemberg, Germany
Leveraging 20+ years of dedicated experience, I am a strategic and results-oriented Global Regulatory Affairs leader, proficient in IVD, Medical Devices, chemical, and environmental regulations. My extensive background has cultivated deep resilience and a remarkable ability to adapt seamlessly across diverse cultural and business environments. I excel in managing multifaceted international regulatory requirements, utilizing my multilingual proficiency to foster effective cross-border collaboration and engage closely with national competent authorities to guide organizations to sustained market success.
Global Strategy & Market Access: Define and steer the global regulatory roadmap for the biocide portfolio, ensuring continuous market access across the EEA and UK by proactively mitigating compliance risks. Key Regulatory Achievement: Directed and secured complex EU approval for the N-MIT-HCl active substance, representing Roche as the sole expert at the ECHA Biocidal Products Committee (BPC). LATAM Regional Leadership: Serve as the dedicated Environmental Regulatory Leader for the LATAM region, providing critical, high-level strategic advisory to senior management on environmental and chemical compliance. Policy & Advocacy: Lead cross-cultural advocacy efforts, leveraging deep regional intelligence to influence emerging policy and safeguard business continuity across diverse LATAM jurisdictions.
Lead the global biocide regulatory strategy and EEA und UK registration projects, while serving as the Environmental Regulatory Expert for the LATAM region.
Managed and ensured 100% compliance with EEA Vigilance responsibilities, including incident reporting and IVDR integration, serving as the central point for post-market quality data requests to support global product lifecycle management.