Director, Regulatory Affairs

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 Full Time Professional Berkeley, CA, US 6 days ago Requisition ID: 1007 Salary Range: $200,000.00 To $235,000.00 Annually 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. 10 - 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 is $200,000-$235,000 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. All employment is decided on the basis of qualifications, merit, and business need #J-18808-Ljbffr Evolving Solution Services