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:
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Develop and execute global CMC regulatory strategies across all phases of development (IND/CTA through BLA/MAA and lifecycle management)
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Provide strategic input on manufacturing changes, comparability approaches, and control strategies
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Anticipate regulatory risks and propose mitigation strategies aligned with agency expectations (FDA, EMA, PMDA, MHRA)
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Lead preparation and authorship of CMC sections (Module 2.3, 3) for:
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INDs / CTAs / Amendments
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Briefing documents and health authority interactions
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BLA/MAA submissions and supplements/variations
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Ensure alignment of CMC documentation with overall regulatory strategy and program timelines
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Oversee document quality, consistency, and compliance with global regulatory requirements
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Serve as CMC regulatory lead for agency interactions (e.g., Type B/C meetings, Scientific Advice)
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Prepare and review CMC briefing materials and response documents
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Support inspection readiness activities, including coordination with Quality and Manufacturing teams
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Provide regulatory guidance on manufacturing process development, analytical methods, specifications, and stability strategies
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Ensure alignment across regions and maintain awareness of evolving regulatory expectations for advanced therapies
Qualifications:
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Bachelor’s degree in life sciences or related field required; advanced degree (MS, PhD, PharmD) preferred.
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~8–12+ years of regulatory affairs experience in biotech/pharma.
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Experience supporting biologics and/or gene/cell therapy products strongly preferred.
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Direct experience with IND/CTA submissions and global regulatory interactions required.
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Deep knowledge of CMC development for biologics/ATMPs, Module 3 structure and expectations, and comparability and change management strategies.
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Familiarity with global regulatory frameworks (FDA, EMA, ICH guidelines)
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Proven ability to operate effectively in a small, fast-paced biotech environment
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Strong cross-functional leadership and influencing skills without direct authority
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Excellent written and verbal communication skills, with the ability to translate complex CMC topics into clear regulatory strategies
Compensation Range and Benefits:
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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.
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Ray Therapeutics also offers annual performance-based bonus, annual equity awards and a comprehensive benefits package.
