Regulatory Affairs Director

16 hours ago

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

Scribe Therapeutics is a molecular engineering company focused on creating best-in-class in vivo therapies that permanently treat the underlying cause of disease. Our team is passionate about developing custom engineered enzymes and delivery modalities as part of a proprietary, evergreen CRISPR by DesignTM platform for CRISPR-based genetic medicine.

We are seeking a highly creative 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 enable building regulatory strategies for CRISPR-based therapeutics. The candidate should have expertise in efficiently navigating the regulatory complexities 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 on the interpretation and application of 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, assist with regulatory interactions, responses to queries from competent authorities, as required for investigational and registration of drugs in the US and ex-US countries.
  • Serve as an internal asset for assigned projects and help 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 submission of 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 the 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; gene editing/gene therapy drug development program experience is strongly preferred.
  • Proven track record supporting CTD format and content for regulatory filings (e.g., 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 process(es) 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, guidance's, 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 is a plus.
  • Experience with regulatory inspections is important to collaborate with the Quality unit.
  • Ability to dissect complex issues of gene editing and gene therapy field and quickly distill key items for discussion with regulatory authorities and guide teams in the preparation of response to regulatory questions.
  • Strong collaboration skills with a congenial attitude is 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.

Salary will be commensurate with experience. We will provide an intellectually stimulating, collegial, and fast-paced environment. If you are ready to engineer the future of therapeutics, then we are excited to hear from you.

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.

At the time of posting, the base pay wage range for this role is $175,000-250,000 per year. The offered pay range will depend on internal equity and the candidate's relevant skills, experience, qualifications, training, and market data. Additional incentives are provided as part of the complete package in addition to comprehensive medical and other benefits.

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