Job Posting

Director, Regulatory Affairs

Reporting to: Chief Medical Officer

Location: Berkeley, CA

About us

Ray Therapeutics is a clinical-stage biopharmaceutical company developing therapies to restore vision in patients affected with retinal degenerations. RayTx utilizes optogenetics to deliver a bioengineered, highly light-sensitive protein to cells in the retina to improve visual function. The company’s lead candidate RTx-015, targeted to retinal ganglion cells, is an adeno-associated virus (AAV) vector based optogenetic therapy currently in Phase 1 testing for retinitis pigmentos. A second program, RTx-021, targeted to retinal bipolar cells, for Stargardt Macular Dystrophy and Geographic Atrophy Age-Related Macular Degeneration is in late-stage preclinical development. Ray Therapeutics is based in the San Francisco Bay Area.

For additional information, please visit www.raytherapeutics.com.

Position Summary:

We are currently seeking an exceptional leader as Director, Regulatory Affairs, to join out team in the mission to restore vision to patients. The Director will work closely with and report to the Chief Medical Officer. This person will be responsible for, in collaboration with development partners, developing and implementing innovative regulatory strategies to support development programs, in compliance with health authority guidelines and regulations. The ideal candidate will have prior experience in AAV gene therapy development and a deep understanding of CMC and Clinical regulations for biologics and gene therapy products. This role requires strategic leadership, cross-functional collaboration, and the ability to navigate evolving regulatory landscapes to advance our pipeline.

The role is based in the Berkeley, CA office with a hybrid work from home/in office requirement.

Essential Duties and Responsibilities:

Lead interactions with global health agencies to inform global regulatory/ registration requirements for assigned programs, developing briefing packages for such engagements
Collaborate with the executive team and functional leads to define regulatory strategies and ensure implimenation
Oversee the compilation, review, and submission of regulatory applications and submissions to agencies, ensuring accuracy, completeness, and timeliness
Collaborate with Technical Operations to develop effective CMC regulatory strategies and partner with them on implementation
Track regulatory interactions, responses, and ensure agency requests are being met
Represent Regulatory Affairs on development teams and support development teams in interpreting and applying regulations and guidance documents
Offer strategic and regulatory compliance input to protocols, reports, and other source documents
Stay updated on global regulatory guidance and regulations, communicating key updates to senior leadership and project teams and anticipate changes in the regulatory landscape and develop proactive strategies accordingly

Qualifications and Experience:

10+ years of regulatory affairs experience
Prior experience with AAV gene therapy programs is highly desirable.
Extensive knowledge of FDA/CBER, EMA, and ICH regulatory guidelines related to gene therapy.
Hands-on experience preparing and submitting INDs, BLAs, CTAs, and MAAs.
Experience interacting with FDA, EMA, and other global health authorities.

Skills & Competencies:

Strong leadership and project management skills in a fast-paced environment.
Excellent communication skills, with the ability to present regulatory strategies to senior leadership and external stakeholders.
Ability to anticipate regulatory challenges and propose risk-mitigation strategies.
Detail-oriented, with a strong scientific foundation and problem-solving abilities.

Working Conditions:

Prolonged periods of being at a stationary desk or work computer
Ability to occasionally adjust, handle, or move objects up to 20 pounds

Ray Therapeutics does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity or expression, national origin, age, disability, veteran status, marital status, or based on an individual’s status in any group or class protected by applicable federal, state, and local law. We invite applications from minorities, women, the disabled, protected veterans and all other qualified applicants.

Ray Therapeutics offers a competitive total rewards package that includes a market competitive base salary, target bonus, and equity in addition to health care benefits.

Please submit please submit your resume and cover letter to: careers@raytherapeutics.com