Regulatory & Compliance - GxP; ICH; CE IVDR; ISO17025;ISO 13485; FDA 21 CFR part11
As a Life Science professional with an MBA and over 15 years of experience in global BioMedTech companies, I’ve distinguished myself as a leader in driving projects that achieve commercial excellence. In my current role, I focus on expanding the market for In Vitro Diagnostic (IVD) products in emerging markets, a goal I’ve consistently met through effective program management and collaboration with senior leadership stakeholders.
Working in a matrix environment, I’ve led cross-functional teams to successfully launch products and services, driving significant revenue growth. Overseeing a portfolio of projects across more than 30 countries, I’ve consistently met revenue forecasts, achieving an impressive $70M target in CAPEX and clinical business.
Beyond leading successful projects, I’ve managed budgets for global market expansion initiatives, ensuring effective resource utilization to achieve desired outcomes. My role heavily relies on collaboration with teams across Commercial Operations, Sales, Strategic Growth, Regulatory Affairs, Legal, Trade Compliance, Marketing, Channel Operations, Purchasing, Supply Chain, and Logistics. Building strong relationships and fostering teamwork have been crucial to achieving shared business goals.
Global role as Program Manager in New Market Expansion with focus on market entry of IVD medical device in the emerging geographies
Biomarker-guided clinical trials and immune monitoring solutions, global central lab and bioanalytical services
A platform-based instrument manufacture offering a wide range of protein tools for research and product quality control in biopharmaceutical research industry.
Lab-automation and service provider - ultra-low volume liquid handling and microarray technologies
Development of a diagnostic lateral flow assay for rapid detection of
procalcitonin (PCT)
Regulatory & Compliance - GxP; ICH; CE IVDR; ISO17025;ISO 13485; FDA 21 CFR part11
Project Management Tools - MS Projects / Asana / Confluence / SmartSheets
Business CRM & Quality - SFDC, SAP, Teamcenter