Director of Regulatory Affairs

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.Ray Therapeutics, Inc. is a clinical stage biotechnology company developing best-in-class vision restoration therapies for people with degenerative retinal diseases independent of genetic mutation. Reporting to the Chief Regulatory Officer, the Director, Regulatory Affairs will play a critical role in leading and executing global regulatory strategy for our clinical-stage programs. This role is ideal for someone who thrives in a fast-paced biotech environment and can operate both strategically and tactically. The Director will play a key role in advancing our pipeline through clinical development and preparing for future regulatory submissions.Key Responsibilities include but are not limited to:Develop and execute global regulatory strategies for assigned programs (IND through late-stage development).Lead preparation, submission, and maintenance of regulatory filings including INDs, CTAs, amendments, annual reports, and briefing documents.Leading Regulatory Agency meeting preparation and participation.Provide regulatory guidance to cross-functional teams (clinical, CMC, nonclinical, quality) to ensure alignment with regulatory requirements and timelines.Oversee and contribute to the authoring and review of regulatory documents (e.g., protocols, investigator brochures, clinical study reports).Monitor and interpret evolving regulatory requirements and communicate implications to internal stakeholders.Support planning and execution of key milestones such as End-of-Phase meetings and pre-NDA/BLA interactions.Manage external regulatory consultants and vendors as needed.Ensure inspection readiness and compliance with applicable regulations and guidelines.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.Strong experience with INDs and early-to-mid stage clinical development; experience with late-stage or NDA/BLA submissions is a plus.Working knowledge of FDA regulations and ICH guidelines; global regulatory experience preferred.Demonstrated ability to work cross-functionally and influence without authority.Strong writing, communication, and organizational skills.Ability to operate independently and adapt in a small company environment.Compensation Range and Benefits:The anticipated base salary range will be 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.All employment is decided on the basis of qualifications, merit, and business needSearch Firm Representatives Please Read CarefullyRay 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 our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Please, no phone calls or emails.