Director, Regulatory Affairs in Berkeley, California at RAY THERAPEUTICS INC
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Job Description
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
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