Graphite Bio is a clinical-stage, next-generation gene editing company harnessing high efficiency targeted gene integration to develop a new class of therapies to potentially cure a wide range of serious and life-threatening diseases. Graphite Bio is pioneering a precision gene editing approach that could enable a variety of applications to transform human health through its potential to achieve one of medicine’s most elusive goals: to precisely “find & replace” any gene in the genome. Graphite Bio’s platform allows it to precisely correct mutations, replace entire disease-causing genes with normal genes or insert new genes into predetermined, safe locations. The company was co-founded by academic pioneers in the fields of gene editing and gene therapy, including Maria Grazia Roncarolo, M.D., and Matthew Porteus, M.D., Ph.D.
The Senior Manager/Associate Director, Regulatory Affairs CMC will be responsible for developing global CMC regulatory strategies and content plans. The primary responsibility is to lead CMC regulatory activities related to cell and gene therapy programs in clinical development. The individual will support CMC Teams and provide direction on the interpretation and application of global CMC regulations and strategical guidance.
What You Will Do:
- Participate as the Regulatory CMC Lead on teams and represent CMC Regulatory Affairs by providing regulatory expertise and input to team recommendations to facilitate successful product development globally
- Actively participate on teams to develop global submission plans that comply with local regulatory requirements and commitments
- Develop and execute global CMC regulatory strategy for one or more drug and cell and gene therapy products
- Lead the preparation of regulatory dossiers for submission to Health Authorities
- Develop and gain agreement with project teams on the regulatory CMC strategy for Health Authority responses as needed
- Drive a culture of continuous improvement to ensure compliance with Graphite Bio standards, regulatory requirements, and expectations; communicates critical issues to Management
- May represent CMC RA on Cross Functional Teams
- May serve as a Single Point of Contact (SPOC)/Subject Matter Expert (SME) on internal and external teams to proactively influence policy and practice on specific areas of CMC regulatory expertise
- Ensure the CMC development and commercial product regulatory strategy meets global regulatory requirements over the lifecycle of the product and is in alignment with the program
- Assure connectivity to the overall global regulatory strategy through partnership and communication with the overall Global Regulatory Leader
- Escalate issues to CMC RA Management that affect registration, regulatory compliance, and continued lifecycle management of the product
- Develop and update contingency plans for issues that may affect registration, regulatory compliance, and the continued lifecycle management of the products in scope
- Effectively and tactfully communicate; build positive relationships and maintain good rapport and credibility
- Review CMC regulatory dossiers for global submissions throughout the product lifecycle
- Provide accurate regulatory assessments of CMC changes to teams/projects and execute regulatory planning and implementation
What You Will Bring:
- A minimum of BS/BA in biological, pharmaceutical, chemical, or engineering sciences with at least 9 years of experience inclusive of post graduate education and/or pharmaceutical or health care industry experience or equivalent is required. An MS, Ph.D., or Pharm. D. degree is preferred
- Solid understanding of biology, chemistry and/or engineering relevant to pharmaceutical industry is required. Experience in the field of CGT is a plus
- A minimum of 2 years of experience developing or contributing to global regulatory strategies in a related function (i.e.R&D, quality, reg compliance) is required
- Experience in biologics, product development/lifecycle management is preferred
- Experience directly writing submission documents that support clinical trials, marketing applications, and lifecycle management is preferred
- Knowledge of EU and FDA regulations is required
- Proactive and independent and self-directed working style
- Excellent communication and organization skills
- Detail oriented team player with effective planning, organization, and execution skills
- Ability to work in a high paced team environment
What Graphite Will Bring:
At Graphite Bio, we are intentionally building a community that is inspired, diverse, and curious. For this role, and all roles, we seek someone who is:
- Determined. You share our mission to bring curative gene editing to patients. And you know the need is urgent.
- People-focused. You prioritize relationships. You value differences and are an excellent listener.
- Adaptable. You seek solutions, even when things change. You prefer to find your way to “yes!”
Graphite Bio is an equal opportunity employer. We believe that our strength is in our differences. Our goal to build a diverse and inclusive team began on day one, and it will never end.
All company employees, regardless of work location, must be fully vaccinated for COVID-19. Fully vaccinated means a person has received all recommended doses in their primary series COVID-19 vaccine. Requests for an accommodation/exemption for medical or religious reasons, as well as under applicable state law, will be considered on a case-by-case basis consistent with applicable law.
To all recruitment agencies
: Graphite Bio does not accept agency resumes or applications. 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 or applications.