Sangamo Therapeutics is a genomic medicine company building value with cutting-edge work across four distinct but complementary technology platforms – gene therapy, cell therapy, in vivo genome editing, and in vivo genome regulation. At Sangamo, we are passionate in developing genomic medicines to transform the lives of patients with serious diseases. We transform lives by building a robust, sustainable, differentiated, innovative, and high value genomic medicine pipeline that addresses patients with life- limiting conditions. Sangamo takes pride in being the first to edit endogenous human genes, first to treat patients with gene edited T cells, and first to treat patients with in vivo genome editing. Our top priority is to meet the needs of patients with commitment and compassion. Along with our commitment to science and to our patients, we also endeavor to create an inclusive environment that promotes and values diversity. Sangamo is a company where individuals can flourish, grow, and develop their expertise.

JOB SUMMARY:
The Director, CMC Regulatory Affairs, will work effectively in a matrixed environment with cross-functional CMC teams, supporting multiple cell and gene therapy programs. A key focus will be to lead the development of regulatory strategies and interaction with global Health Authorities; provide strategic input and regulatory advice to the project teams on clinical and pre-clinical programs to ensure compliance with applicable regulations and health authority expectations. The successful candidate with help plan, prepare, and review regulatory documentation to ensure its suitability for submission to health authorities.

ESSENTIAL FUNCTIONS:
Essential functions include, but are not limited to, the following:

• Provide regulatory CMC strategic and practical hands-on support in the development of multiple innovative in vivo and ex vivo cellular gene therapy and gene editing products for the treatment of serious diseases.
• Lead and support global CMC regulatory strategies for assigned programs, in association with cross-functional teams and senior management.
• Responsible for ensuring appropriate CMC regulatory strategy to assigned project teams to ensure compliance with applicable regulations and authority expectations
• Actively seeks out knowledge of overall corporate planning and other general factors that affect the regulatory positions taken within the company, and with global health authorities, and incorporates this knowledge into submission planning
• Provides regulatory support on technical and quality activities, such as manufacturing process development, specifications, in process controls, stability protocols, and change control management, and quality and compliance initiatives
• Review clinical trial label content against country specific requirements
• Support, prepare, review, and track regulatory submission and maintenance processes to support INDs, CTAs, BLAs, MAAs to ensure compliance with ICH, as well as country specific requirements
• Lead or support interactions with regulatory health authorities
• Responsible for effective coordination efforts of multifunctional CMC disciplines for timely completion of project milestones
• Evaluate relevant global regulations and guidelines critically for their impact on development activities and regulatory plans
• Responsible for working closely and successfully with regulatory colleagues to ensure successful and timely completion of project assignments
• Evaluate proposed manufacturing changes for impact to IND/ CTA filings, and provide a regulatory assessment and a submission strategy for optimal implementation of changes