Regulatory Affairs Director

4 weeks ago

Fremont, California, United States Scribe Therapeutics Full time
Job Description

Scribe Therapeutics is a molecular engineering company focused on creating innovative in vivo therapies that address the root causes of diseases. Our team of experts, including CRISPR inventors and leading molecular engineers, is dedicated to developing custom engineered enzymes and delivery modalities as part of our proprietary CRISPR by DesignTM platform for CRISPR-based genetic medicine.

We are seeking a highly skilled and motivated individual to join our team as an Associate Director/Director, Regulatory Affairs. The ideal candidate will have a passion for working collaboratively with nonclinical, clinical, and CMC team members to develop regulatory strategies for CRISPR-based therapeutics. Additionally, the candidate should have expertise in navigating the complex regulatory landscape inherent in gene editing programs.

Key Responsibilities:
  • Lead our growing regulatory functions and execute global regulatory strategies across nonclinical, clinical, quality, and CMC functions for gene editing therapies.
  • Assist project teams in interpreting and applying relevant regulatory guidances and requirements, ensuring compliance.
  • Present regulatory strategies and issues at team and governance meetings.
  • Help 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, helping to progress and learning between project team members and regulatory requirements.
  • Collaborate cross-functionally with nonclinical, CMC, and quality leadership and stakeholders on planning and coordinating regulatory submissions and interactions with health authorities.
  • Prepare teams for Health Authority meetings and inspections.
  • Create, review, assemble, and submit regulatory documentation, including INDs and CTAs, and amendments, annual reports.
  • 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.

Required Skills and Background:

  • Minimum 8-10 years of relevant regulatory experience in the biotech and pharmaceutical industry, with some supervisory experience, and gene editing/gene therapy drug development program experience is strongly preferred.
  • Proven track record supporting CTD format and content for regulatory filings, such as INDs, CTAs, NDAs/BLAs.
  • Serve as the primary liaison with internal stakeholders and external collaborators on regulatory responsibilities and ensure timely support of regulatory filings, including IND/IMPD and associated updates.
  • Develop and maintain processes for product life cycle management from Research to Development and into Clinic.
  • Interpret and communicate regulatory requirements to internal and external stakeholders, providing guidance on compliance strategies and potential regulatory risks.
  • Stay abreast of emerging regulations, guidances, standards, and industry trends relevant to cell and gene therapy products and proactively integrate regulatory intelligence into development strategies.
  • Exceptional communication skills to mentor, guide, and train in compliance-related matters are a plus.
  • Experience with regulatory inspections is important to collaborate with the Quality unit.
  • Ability to dissect complex issues in the gene editing and gene therapy field and quickly distill key items for discussion with regulatory authorities and guide teams in preparing responses to regulatory questions.
  • Strong collaboration skills with a congenial attitude are strongly preferred.
  • Experience managing complex schedules and shifting priorities in a dynamic environment is a plus.
  • Finding ways to create structure and maintain timelines in a dynamic start-up environment will be a very important trait.

We offer a competitive salary, commensurate with experience, and a comprehensive benefits package. If you are ready to engineer the future of therapeutics, we encourage you to apply. Visit us at www.scribetx.com.

We are committed to creating a diverse environment and are proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, disability, age, or veteran status.

Additional incentives are provided as part of the complete package, including comprehensive medical and other benefits.

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