Michelle Luu

Provide regulatory strategies, identify risks, and propose risk mitigation on CMC regulatory submissions for INDs, CTAs, and NDA. Responsible for preparing and reviewing technically complex regulatory CMC submissions, CMC data package, and CMC responses to health authority agencies. Lead, coordinate, and maintain regulatory filings for domestic and international regions; provide complete and appropriate documentation necessary for timely submissions. Represent Reg CMC on assigned projects and assure the progress of projects by providing direction solutions and feedback to the team.

Prepare, author and manage regulatory submissions in various phases of development and global marketing applications for small molecules, biologics, drug/device combination products. Support lifecycle management of marketed products by planning and submitting post-approval changes, annual reports, variations and renewals. Communicate and collaborate with cross-functional teams, and key partners for CMC regulatory strategies, responses to agency questions, compliance activities, and submissions. Evaluate change proposals for global regulatory impact and determination of global submission variations. Maintain regulatory documentation and CMC submission templates.

Started at Allergan as a chemist working on development of ocular drug delivery systems and extended release technologies. Promoted to scientist in non-clinical development leading a team to manufacture ocular implants for non-clinical studies. Transitioned to regulatory CMC as a product owner and lead CMC technical writer for small molecules and biologics.

Desiged and directed studies for manufacture and characterization of GLP formulations for toxicology, pharmacokinetics and toxicokinetics studies. Represent the department on project teams, CMC teams to achieve project milestones, activities and budgets for non-clinical studies.

Designed and performed formulation screening, drug release in-vitro testing, stability studies and different sterilization processes. Coordinated activities with different departments to provide support for studies to assess safety, toxicity and efficacy of drug substance and drug formulations. Evaluated different polymers for protein/peptide delivery from ocular drug delivery system. Evaluations include polymer properties, processing assessment, implant formulation optimization and production, in vitro drug release studies and in-vivo toxicity studies.