Graphite Bio, Inc. is a dynamic clinical stage biotechnology company focused on harnessing targeted DNA integration techniques to cure disease. Graphite uses next generation and emerging CRISPR and AAV based technology platforms for curative gene correction therapies for serious and life threatening genetic conditions. We are seeking passionate individuals who are dedicated to transforming ground-breaking science to dramatically improve the lives of patients, and to working collaboratively in a supportive, fast-paced and exciting environment.
Graphite is seeking an outstanding candidate to build, drive and direct the company’s regulatory strategy and operations in order to accelerate our research and clinical development toward commercialization. The ideal individual should be a motivated and creative leader who has a deep understanding of the various regulations overseeing clinical development and experience to match; this includes prospective thinking and problem-solving to anticipate challenges. Experience should include the creation and filing of INDs, CTAs/BLAs, briefing packages, orphan drug applications and various other important regulatory documents and associated designations. Likewise, experiences working in rare disorders and with pediatric patients is key. Critical thinking about study designs, forward thinking about labeling requirements, manufacturing, and scientific knowledge is needed to ensure the company is working in the best interest of providing potential gene therapy therapeutics to patients.
Develop short and long-range regulatory strategies for the Company, working closely with both research and development colleagues, to ensure plans are in place for efficient and expedient drug development
Oversee all regulatory filings and interactions, including authorship of critical documents as needed with a keen eye towards applying scientific knowledge and business strategy to create robust messages
Manage all operational aspects of preparing compliant submissions to Regulatory Agencies.
Serve as primary interface with FDA and various other competent authorities
Manage and build the regulatory and electronic documentation infrastructure
Manage regulatory submission timelines in accordance with project plans. Maintains submission tracking information and informs project teams and management on real-time status of business-critical submissions and risk and timeline management.
Oversee the evaluation and analysis of the impact of trends relative to government regulatory activities, relying heavily on strategic thinking, prioritization, and problem-solving skills
Review product development and in/out-licensing and partnership opportunities
Serve as a resourceful and collaborative team member to help inform strategic decisions
This opportunity is full-time only. No contractors, consultancies or recruiters will be considered. Graphite Bio is proud to be an equal opportunity employer
7+ years' experience in pharmaceutical regulatory activities
Minimum BS or BA in science/technology or an equivalent combination of education and experience.
Excellent communication and collaboration skills, including working closely with internal and external team members
Current and strong working knowledge of electronic document and submission standards and requirements applicable to the US regulatory environment and ICH; EMA and other global agencies preferred
Advanced skills in the use of MS Word, Adobe Professional, and other document publishing tools.
Experienced in eCTD publishing.
Experienced in managing web-based content and document management environments (eg SharePoint, EDMS solutions).
Proven project management skills to support the planning and coordination of large regulatory submissions and appropriate regulatory inspections.
Ability to work independently and to be innovative in tackling operational challenges.
Demonstrated success leading and scaling teamsand proven ability to positively impact company culture and demonstrate flexibility in a fast-paced environment
Inspiring team building and management skillswith a vision for how to build and scale an organization
This opportunity is full-time only. No contractors, consultancies or recruiters will be considered. Graphite Bio is proud to be an equal opportunity employer.
To all recruitment agencies: Graphite Bio does not accept agency resumes. Please do not forward resumes to our jobs alias, or Graphite Bio employees. Graphite Bio is not responsible for any fees related to unsolicited resumes.
Internal Number: 32
A next-generation gene-editing company focused on fixing genes through targeted DNA integration to cure serious diseases