An innovative oncology-focused biotechnology organization in the Boston area is seeking a Senior Manager, Regulatory Affairs CMC to support the development of its lead investigational program as it advances toward the clinic.

This position will play a critical role in driving CMC regulatory strategy and execution during a pivotal phase of growth. Working closely with internal teams and external partners, this individual will help ensure global regulatory compliance for all CMC related submissions.

Key Responsibilities:

• Develop and lead CMC regulatory strategy for investigational products
• Prepare and submit CMC sections of INDs, IMPDs, and other global regulatory filings
• Serve as regulatory liaison between CMC, QA, and external manufacturing partners
• Monitor evolving regulatory requirements and ensure internal practices remain compliant
• Support regulatory assessments for process changes and provide guidance on global requirements

Qualifications:

• Bachelor’s or advanced degree in life sciences, chemistry, or related discipline
• 6+ years of regulatory affairs experience with a strong focus on CMC
• Hands-on experience with IND preparation and early development-stage programs
• In-depth knowledge of FDA, ICH, and global CMC regulatory expectations
• Experience working in oncology and/or with small molecule products is a plus
• Strong communication, project management, and cross-functional collaboration skills