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Sr. Director, Regulatory Affairs

Scribe Therapeutics

Scribe Therapeutics

Legal
Alameda, CA, USA
Posted on Tuesday, March 12, 2024

Scribe Therapeutics is a molecular engineering company focused on creating best-in-class in vivo therapies that permanently treat the underlying cause of disease. Founded by CRISPR inventors and leading molecular engineers Benjamin Oakes, Brett Staahl, David Savage, and Jennifer Doudna, Scribe is overcoming the limitations of current genome editing technologies by developing custom engineered enzymes and delivery modalities as part of a proprietary, evergreen CRISPR by Design™ platform for CRISPR-based genetic medicine.

We are seeking a highly creative, passionate, and motivated individual to join us in our quest to develop the next generation of CRISPR-based therapeutics. The current role is for a Senior Director, Regulatory Affairs to join our team and advance our platform. The candidate should have a passion for working collaboratively with nonclinical, clinical and CMC team members to enable building regulatory strategies for CRISPR-based therapeutics. Furthermore, the candidate would offer expertise in efficiently navigating the regulatory complexities inherent in gene editing programs.

Key Responsibilities:

  • Develop and execute global Regulatory strategies across nonclinical, clinical, quality and CMC functions, for gene editing therapies, ensuring alignment with corporate objectives/timelines and regulatory compliance
  • Provide advice and guidance to project teams on the interpretation and application of relevant regulatory guidances and requirements and review processes
  • Present Regulatory strategies and issues at team and governance meetings
  • Play a key role in planning, preparation, drafting and review of regulatory documentation, including IND/CTA/GMO/BLA/MAA, 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 primary health authority contact for assigned projects and foster positive and effective working relationships between project team members and health authority reviewers
  • 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 and lead Health Authority meetings
  • Manage and participate in the creation, review, assembly and submission of regulatory documentation including INDs and CTAs and amendments, annual reports
  • Ensure consistency/completeness/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 years of relevant regulatory leadership experience in the biotech and pharmaceutical industry; gene editing/gene therapy drug development program experience is a requirement
  • Proven track record supporting CTD format and content for regulatory filings (e.g., INDs, CTAs, NDAs/BLAs)
  • Experience in establishing regulatory capabilities and functions
  • Demonstrated ability to develop and maintain excellent working relationships with EU regulatory agencies and US FDA and similar key international regulatory agencies, including the planning/implementation of agency meetings
  • Excellent interpersonal communication and presentation skills to facilitate collaboration across functions and build successful relationships with internal and external stakeholders, as well as external parties
  • Experience managing complex schedules and shifting priorities in a dynamic environment
  • 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
  • Entrepreneurial thinker and attitude, highly creative, and comfortable with hands-on startup culture

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! 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.

At the time of posting, the base pay wage range for this role is $230,000-285,000 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.