Director, Regulatory Affairs - CMC

If you are unable to complete this application due to a disability, contact this employer to ask for an accommodation or an alternative application process. Director, Regulatory Affairs - CMC Full Time Professional Berkeley, CA, US 28 days ago Requisition ID: 1008 Salary Range: $200,000.00 To $235,000.00 Annually Ray Therapeutics mission is to restore vision to people with retinal degenerations. RayTx is using a novel bioengineered optogenetic protein optimized for human vision delivered by AAV to restore visual function in a mutation agnostic approach and without the need for light enhancing eyewear. The company is developing its lead candidate RTx-015 in retinitis pigmentosa, a degenerative retinal disease with significant unmet medical need as well as a pipeline to treat both rare and large market indications. Reporting to the Chief Regulatory Officer, the Director, Regulatory Affairs - CMC- willserve 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. 10 -12+ years of regulatory affairs experience in biotech/pharma. Experience supporting biologics required; gene/cell therapy products strongly preferred. Direct experience with IND/CTA and BLA 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: $200,000 to $235,000, 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. At Ray Therapeutics, we celebrate diversity and are committed to creating an inclusive environment for all employees; providing an environment of mutual respect where equal employment opportunities are available to all applicants and teammates without regard to race, color, religion, sex, pregnancy, national origin, age, physical and mental disability, marital status, sexual orientation, gender identity, gender expression, genetic information, military and veteran status, and any other characteristic protected by applicable law. All employment is decided on the basis of qualifications, merit, and business need. Search Firm Representatives Please Read Carefully Ray Therapeutics does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of Ray Therapeutics. #J-18808-Ljbffr Evolving Solution Services