Susan Batcha Email & Phone Number

Global Regulatory Lead CMC Liaison (biological products) responsible for global regulatory strategies and submissions for new development programs and new product approvals, life-cycle management and continued regulatory compliance.Lead project teams in preparation of global dossiers (INDs, BLAs and post-approval supplements), global Health Authority interactions and negotiations as appropriate; setting objectives, preparing briefing books, coordinating and planning rehearsals for meetings.

Nutley, New Jersey

Develop and negotiate CMC-related regulatory strategies, policies, and plans for new development programs and new product approvals, life-cycle management and continued regulatory compliance.Lead project teams in preparation of global dossiers (INDs, BLAs and post-approval supplements), regional Health Authority interactions and negotiations as appropriate; setting objectives, preparing briefing books, coordinating and planning rehearsals for meetings.Train and mentor new hires.

Houston, Texas Area

As regulatory and compliance officer, established quality systems including document control, complaint handling, change control, training, auditing, production and validation in accordance with the FDA Quality System Regulation and ISO 9001. As VP of Manufacturing, responsible for directing all production aspects for a global in-vitro diagnostic manufacturer including Monoclonal Antibody production, Reagent Manufacturing, Filtration and Sterilization and Filling and Labeling.