Senior Manager Regulatory Affairs

Job/Role Title: Senior Manager, Regulatory AffairsReporting to: Chief Regulatory OfficerLocation: Hybrid (Berkeley, CA)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 Senior Manager, Regulatory Affairs will play a critical role in advancing the company’s clinical-stage pipeline by developing and executing regulatory strategies to support global development programs. This individual will serve as a key contributor to regulatory submissions, agency interactions, and cross-functional planning in a fast-paced environment.Key Responsibilities include but are not limited to:Develop and implement regulatory strategies for clinical-stage programs in alignment with corporate objectivesLead preparation, review, and submission of regulatory documents, including INDs, CTAs, amendments, annual reports, and briefing packagesCoordinate and author regulatory sections of key submissions (e.g., protocols, investigator brochures, IND modules)Serve as primary regulatory contact for assigned programs, collaborating closely with Clinical, CMC, Nonclinical, and Quality teamsManage interactions with regulatory agencies (e.g., FDA, EMA), including meeting requests, briefing documents, and responses to information requestsEnsure compliance with applicable global regulatory requirements and guidelinesProvide regulatory guidance to internal teams to support development plans and decision-makingTrack regulatory milestones and proactively identify risks and mitigation strategiesSupport development and improvement of regulatory processes, systems, and templatesQualifications:Bachelor’s degree in life sciences or related field required; advanced degree (MS, PhD, PharmD) preferredMinimum 6 years of regulatory affairs experience in the biotechnology industryDirect experience supporting IND/CTA submissions and early-phase clinical developmentStrong knowledge of FDA regulations and ICH guidelines; familiarity with ex-US regulatory frameworks is a plusProven ability to work cross-functionally in a small, dynamic organizationExcellent writing, communication, and project management skillsAbility to travel up to 20%Ability to work from our Berkeley, CA office a minimum of 2 days per weekPlease note that you must reside within assigned territory and note territory when applyingAt 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.Compensation Range and Benefits:For this role, the anticipated base salary range: $170,000 to $185,000, 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.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.