Director of Regulatory Affairs
About the role
The Director, Regulatory Affairs will lead and execute global regulatory strategy for Ray Therapeutics' clinical-stage programs, from IND through late-stage development. They will prepare and submit regulatory filings, lead Regulatory Agency meetings, provide guidance to cross-functional teams, and ensure compliance with all relevant regulations.
Responsibilities
- 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
- Prepare and participate in Regulatory Agency meetings
- Provide regulatory guidance to cross-functional teams (clinical, CMC, nonclinical, quality) to ensure alignment with regulatory requirements and timelines
- Contribute to the authoring and review of regulatory documents (e.g., protocols, investigator brochures, clinical study reports)
- Maintain oversight of regulatory document management and ensure compliance with applicable regulations and guidelines
- 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
Requirements
- 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
- Ability to work 3 days per week in our Berkeley, CA office
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
- Ability to work 3 days per week in our Berkeley, CA office
Skills
- Strategic thinking and execution
- Regulatory affairs expertise
- Collaborative leadership
- Compliance and documentation proficiency
- Interpersonal and communication skills
Benefits
Ray Therapeutics offers an annual performance-based bonus, annual equity awards, and a comprehensive benefits package.
Pay
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.
Schedule
The Director, Regulatory Affairs will work 3 days per week in our Berkeley, CA office.