Regulatory Affairs Associate

• Feb 2021 - Present

• Collects and coordinates information across a cross-functional team to prepare regulatory documentation for submission to agencies or commercial partners.• Writes device submissions to be reviewed by regulatory authorities. • Develops regulatory strategies for products in the United States and on the global stage. • Reviews and documents changes to existing products and SOPs to ensure continued regulatory compliance. • Creates and maintains regulatory affairs registrations and licenses. • Communicates effectively with regulatory agencies and various key partners across the product life cycle. • Stays up to date with changing regulations in various geographies (United States, European Union, Canada, and Australia).

Laboratory Project Coordinator

• Apr 2018 - Feb 2021

• Formalized, implemented, and managed the product stability program. • Coordinated aspects of development projects related to product chemistry. • Managed the analytical chemistry program; directed test method development, validation/verification, and transfer with external laboratory partners and contract manufacturers. • Authored protocols, reports, and technical documents intended for submission to regulatory authorities. • Provided effective and engaging leadership as a manager within the chemistry team.• Actively identified and mitigated project risks.

Chemistry Laboratory Technician

• Apr 2016 - Apr 2018

• Developed and validated wet chemistry analytical methods per ICH guidelines. • Executed testing under good laboratory practices. • Drafted protocols and reports for shelf-life studies and analytical test methods. • Effectively prioritized tasks and managed self for the timely delivery of action items.

Laboratory Intern

• Sep 2014 - Apr 2016