Senior Director of Regulatory CMC
Manager: Global VP, Regulatory
Department: Regulatory Affairs
Location: Brisbane, CA
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.
We are seeking top talent to join our mission. Let’s build a better future together.
Sangamo Therapeutics is seeking a Senior Director of Regulatory CMC. The position is responsible for working in a fast growing, highly dynamic biotechnology environment, closely interacting with our in-house Regulatory Group and CMC Technical Operations and Quality teams as well as contract manufacturing organizations, external experts and strategic partners. The position will serve to provide a strong Regulatory leadership perspective in support of developing innovative CMC regulatory strategies for multiple in vivo and ex vivo cellular gene therapy and gene editing products in current and future clinical development. The position will also be responsible for hands on management of the collaborative preparation and submission of high‑quality CMC sections of INDs, CTAs, and original marketing applications (BLAs/MAAs).
- 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 rare or life threatening diseases
- Lead CMC Regulatory activities and manage highly detailed regulatory timelines to achievement of goals
- Lead CMC regulatory interactions with health authorities including the preparation of briefing packages, conduct of meeting and documentation of meetings
- Manage and implement interdisciplinary planning, preparation and submission of high-quality CMC‑related regulatory sections submissions and applications in the US, EU, and ROW
- Ensure that CMC-related applications and/or sections, including INDs/CTAs, investigator brochures and pediatric investigation plans, and MAAs/BLAs are complete, well written, and meet all relevant requirements
- Support negotiations with regulatory agencies to resolve CMC issues and shepherd proactive interactions with regulators; support interactions with regulatory agencies during GMP and pre-approval inspections
- Ensure adherence to CMC regulatory guidelines relevant for the development of in vivo and ex vivo cellular gene therapy and gene editing products; review and approve, as necessary, internal documentation to ensure conformance with regulations and existing regulatory approvals
- Proactively assess and provide flexible and practical guidance to proposed manufacturing process changes; provide strategic regulatory guidance to enable global implementation
- Partner and work very closely with Manufacturing, Quality, Nonclinical, Clinical and Regulatory project leads to ensure achievement of submission deadlines and obtain timely approvals of Sangamo’s CMC‑related applications
- Lead regulatory intelligence activities; monitor regulatory guidelines and trends; obtain and interpret global CMC regulations and guidance and provide regulatory advice to Sangamo’s in-house CMC teams and Project/Product teams
- Coach, mentor, and develop an effective CMC Regulatory team
EDUCATION, EXPERIENCE AND SKILLS REQUIREMENTS:
- Extremely strong biological sciences background essential. Bachelor’s degree in life sciences such as molecular biology, biochemistry, virology and cell biology; a higher degree, such as MS or PhD very desirable
- 15 years of relevant biopharmaceutical industry experience, with at least 5 years of hands on experience in CMC-focused Regulatory Affairs in biologics, preferably with experience of regulatory interactions and BLA filings, and ideally in an area related to in vivo gene therapy, viral vectors, and ex vivo cellular gene therapy
- Experience in direct interactions supporting health authorities, submissions, meetings, and GMP inspections
- Experience in supervising and building effective regulatory teams
- Excellent written and very strong communication skills, strong technical knowledge, including CMC‑regulatory writing
- Strong leadership qualities including innovative and flexible strategic thinking
with detail oriented, science-based reasoning skills
- Ability to execute and follow-through to completion and documentation
- Ability to work effectively in a collaborative team environment where results are achieved through influence and the incorporation of multiple points of view
- Independently motivated and solution oriented
- Very strong knowledge of current Good Manufacturing Practices (GMP), drug and biologics development regulations and guidelines including ICH, FDA and EMA guidelines
- Ready to embrace a culture of flexibility and innovation, with a very high degree of urgency and commitment to translating ground-breaking science into genomic therapies that transform patients' lives
Sangamo is an equal opportunity employer
The above reflects management’s definition of essential functions for this position but does not restrict the tasks that may be assigned. The above duties are representative only; management may assign or reassign duties and responsibilities to this position at any time.