Director of Regulatory Affairs

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.

• 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.

• 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.
• You have 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.
• You have demonstrated the 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.
• Ability to work 3 days per week in our Berkeley, CA office.

All employment is decided on the basis of qualifications, merit, and business need

• The anticipated base salary range is $200,000-$250,000 and 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.