Senior Scientist, Regulatory Affairs-Chemistry, Manufacturing and Control

Senior Scientist role overseeing Chemistry, Manufacturing and Control regulatory strategy and documentation for biological products throughout development and post-approval lifecycle. Lead cross-functional teams to ensure compliance with global regulatory requirements and manage submissions to health authorities.

Responsibilities

• Serve as CMC project lead and provide regulatory strategy for assigned biological programs
• Develop and execute robust global CMC regulatory strategies aligned with health authority requirements
• Manage preparation and submission of CMC regulatory documents including INDs, BLAs, and MAAs
• Identify regulatory risks and escalate issues to senior regulatory and safety management
• Ensure all activities maintain unwavering focus on regulatory compliance and operational standards

Requirements

• Bachelor's degree in chemistry, chemical engineering, biology, microbiology, virology, molecular biology, or biochemistry
• 5+ years regulatory CMC experience in biologics or vaccine development, manufacturing, or testing
• Expertise in eCTD, regulatory documentation, and compliance frameworks
• Strong knowledge of biologics regulatory affairs and CMC requirements
• Experience managing IND applications, BLAs, MAAs, and post-approval submissions
• Detail-oriented with excellent interpersonal and communication skills

Compensation: $117,000–$184,200 base