Senior Manager/Associate Director, Regulatory CMC Consultant (REMOTE)
K
Kaztronix
📍 United States, Virginia, United States
Job Description
Key Responsibilities
Regulatory Strategy & Execution
Regulatory Strategy & Execution
- Lead Global Strategy: Formulate innovative, accelerated CMC regulatory strategies for Client advanced therapy medicinal products (ATMPs), focusing on AAV-mediated gene therapies, antisense oligonucleotides (ASOs), and alternative CNS platforms.
- Lifecycle Filings: Lead the authoring, technical review, and global submission of high-quality CMC sections (Module 2 and Module 3) for INDs, IMPDs, CTAs, and future BLAs/MAAs.
- Agency Interactions: Direct or support formal interactions, briefing document preparation, and Type B/C meetings with the FDA, EMA, and other major health authorities on complex gene therapy manufacturing topics.
- Regulatory Intelligence: Track evolving global regulations impacting cell and gene therapies, including FDA tissue-specific guidance, GMO applications in Europe, and expedite...