Job Summary

A company is looking for a CMC Regulatory Affairs Senior Manager Principal Scientist.

Key Responsibilities:

• Participate in the development and execution of Regulatory CMC strategies for gene therapy programs
• Generate CMC-related regulatory documentation and submissions in compliance with regulations
• Assess and communicate CMC regulatory requirements and provide guidance on compliance

Required Qualifications:

• Bachelors or Masters Degree in life science field or related scientific discipline
• 3+ years of experience in Regulatory CMC or related field
• Experience with regulatory submissions and viral vector gene therapy products preferred
• Prior successful filing of IND/CTA and/or BLA/NDA/MAA preferred
• Working knowledge of FDA, EMA, and ICH regulations/guidance