Associate Director - Regulatory Affairs
22 hours ago
🏢 In-office - Bay Area
Description
• Scribe Therapeutics is focused on developing CRISPR-based genetic medicine • Lead growing regulatory functions • Execute global regulatory strategies for gene editing therapies • Assist project teams on regulatory guidances and requirements • Present regulatory strategies at governance meetings • Prepare and review regulatory documentation including IND/CTA/GMO/BLA/MAA • Serve as an internal asset for assigned projects • Collaborate with stakeholders on regulatory submissions and interactions • Prepare teams for Health Authority meetings and inspections • Ensure consistency and adherence in regulatory submissions • Provide regulatory review and impact assessments of proposed changes
Requirements
• Minimum 8-10 years of relevant regulatory experience in biotech or pharmaceutical industry • Gene editing/gene therapy drug development program experience is strongly preferred • Proven track record supporting CTD format and content for regulatory filings • Primary liaison with internal stakeholders and external collaborators on regulatory responsibilities • 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 • Stay abreast of emerging regulations, guidance’s, and industry trends relevant to cell and gene therapy • Exceptional communication skills to mentor, guide, and train in compliance related matters • Experience with regulatory inspections to collaborate with the Quality unit • Ability to dissect complex issues of gene editing and gene therapy quickly and accurately • Strong collaboration skills with a congenial attitude • Experience managing complex schedules and shifting priorities • Finding ways to create structure and maintain timelines in a dynamic environment
Benefits
• Comprehensive medical and other benefits • Additional incentives as part of the complete package
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