Associate Director, Regulatory Affairs, CMC

Associate Director, Regulatory Affairs, CMC

RAY THERAPEUTICS INC

Berkeley, CA Job Details Full-time $175,000 - $195,000 a year 12 hours ago Qualifications FDA submissions Bachelor's degree Regulatory submissions Full Job Description Reporting to the Chief Regulatory Officer, the Associate Director, Regulatory Affairs will serve as a key member of the Regulatory organization, responsible for developing and executing global Chemistry, Manufacturing, and Controls (CMC) regulatory strategies for clinical-stage gene therapy programs. This individual will partner cross-functionally with CMC, Technical Operations, Quality, and Clinical teams to ensure timely, compliant, and high-quality regulatory submissions and lifecycle management activities. Key Responsibilities include but are not limited to: Develop and execute global CMC regulatory strategies across all phases of development (IND/CTA through BLA/MAA and lifecycle management) Provide strategic input on manufacturing changes, comparability approaches, and control strategies Anticipate regulatory risks and propose mitigation strategies aligned with agency expectations (FDA, EMA, PMDA, MHRA) Lead preparation and authorship of CMC sections (Module 2.3, 3) for: INDs / CTAs / Amendments Briefing documents and health authority interactions BLA/MAA submissions and supplements/variations Ensure alignment of CMC documentation with overall regulatory strategy and program timelines Oversee document quality, consistency, and compliance with global regulatory requirements Serve as CMC regulatory lead for agency interactions (e.g., Type B/C meetings, Scientific Advice) Prepare and review CMC briefing materials and response documents Support inspection readiness activities, including coordination with Quality and Manufacturing teams Provide regulatory guidance on manufacturing process development, analytical methods, specifications, and stability strategies Ensure alignment across regions and maintain awareness of evolving regulatory expectations for advanced therapies

Qualifications:

Bachelor's degree in life sciences or related field required; advanced degree (MS, PhD, PharmD) preferred. ~8-12+ years of regulatory affairs experience in biotech/pharma. Experience supporting biologics and/or gene/cell therapy products strongly preferred. Direct experience with IND/CTA submissions and global regulatory interactions required. Deep knowledge of CMC development for biologics/ATMPs, Module 3 structure and expectations, and comparability and change management strategies. Familiarity with global regulatory frameworks (FDA, EMA, ICH guidelines) Proven ability to operate effectively in a small, fast-paced biotech environment Strong cross-functional leadership and influencing skills without direct authority Excellent written and verbal communication skills, with the ability to translate complex CMC topics into clear regulatory strategies

Compensation Range and Benefits:

For this role, the anticipated base salary range: $175,000 to $195,000, based on the candidate's professional experience level. The final salary offered for this position may take into account a number of factors including, but not limited to skills, education, and experience. Ray Therapeutics also offers annual performance-based bonus, annual equity awards and a comprehensive benefits package.