Michelle Lee

Experience

1. Director of Regulatory Operations

   Tersera Therapeutics

   May 2023 — Present · Deerfield, IL, US

   Manage regulatory operations within TerSera for given products for both CMC and Clinical areas.• Create, modify or maintain Regulatory Affairs policies and procedures to maintain a high level of regulatory compliance.•Manage Regulatory Affairs interactions with health authorities and set and maintain high standards and expectations of partners, contractors and vendors who support TerSera operations.•Provide strategic direction in minimizing regulatory and compliance risks.•Define organize and file all supplements and periodic updates to applications, as required.•Direct and manage necessary consultants and contractual support to assure timely actions, establish performance objectives, and evaluate staff performance.•Provide regulatory support in the review of marketing and promotional material submitted to FDA.•Interface with Medical Affairs team on maintaining a strong Pharmacovigilance system of monitoring and reporting requirements.•Maintain key contacts in the regulatory areas to keep abreast of domestic and global regulatory developments.•Participate in management and project teams as necessary.•Ensure Product Annual Reports are submittedtimely manner.•Execute other projects as required to meet department and company objectives.

Skills

• Regulatory Affairs
• Pharmaceutical Industry