Regulatory Affairs Director

2 days ago

Alameda, California, United States Scribe Therapeutics Full time
Job Title: Associate Director/Director, Regulatory Affairs

Scribe Therapeutics is a molecular engineering company focused on creating innovative in vivo therapies that address the root causes of disease. Our team is dedicated to developing best-in-class CRISPR-based genetic medicines.

Job Summary

We are seeking a highly skilled and motivated individual to join our team as an Associate Director/Director, Regulatory Affairs. The successful candidate will have a strong background in regulatory affairs, with a focus on gene editing and gene therapy drug development programs. The role will involve leading our growing regulatory functions, executing global regulatory strategies, and ensuring compliance with regulatory requirements.

Key Responsibilities
  • Develop and implement regulatory strategies for CRISPR-based therapeutics, ensuring alignment with corporate objectives and timelines.
  • Collaborate with nonclinical, clinical, and CMC teams to ensure regulatory compliance and efficient navigation of regulatory complexities.
  • Present regulatory strategies and issues at team and governance meetings.
  • Prepare, draft, and review regulatory documentation, including IND/CTA/GMO/BLA/MAA, and assist with regulatory interactions and responses to queries from competent authorities.
  • Serve as an internal asset for assigned projects, providing regulatory expertise and guidance to project teams.
  • Collaborate with cross-functional teams to plan and coordinate regulatory submissions and interactions with health authorities.
  • Prepare teams for Health Authority meetings and inspections.
  • Ensure consistency, completeness, and adherence to standards for all regulatory submissions.
  • Provide regulatory review and impact/implementation assessment of proposed Change Control records and manage associated regulatory notifications.
Requirements
  • Minimum 8-10 years of relevant regulatory experience in the biotech and pharmaceutical industry, with some supervisory experience.
  • Proven track record supporting CTD format and content for regulatory filings (e.g., INDs, CTAs, NDAs/BLAs).
  • Strong communication and collaboration skills, with the ability to mentor, guide, and train in compliance-related matters.
  • Experience with regulatory inspections and ability to dissect complex issues in the gene editing and gene therapy field.
  • Ability to work in a dynamic environment, managing complex schedules and shifting priorities.
What We Offer

We offer a competitive salary, comprehensive medical and other benefits, and a fast-paced, intellectually stimulating environment. If you are passionate about gene editing and gene therapy, and have a strong background in regulatory affairs, we encourage you to apply.

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