About Sonoma Biotherapeutics

Sonoma Biotherapeutics is a South San Francisco and Seattle-based company leading the development of adoptive T-reg therapies cell for autoimmune and degenerative diseases. Using next generation genome editing and target-specific cell therapy, Sonoma is focused on developing its best-in-class platform across the entire spectrum of T-reg cell therapeutic capabilities. Founded by pioneers in Treg biology and cell therapy, the company brings together leading expertise and proprietary methodologies for the discovery and development of disease modifying and curative therapies. More information at www.sonomabio.com.

Job Purpose/Summary:

We seek an experienced Regulatory professional to manage regulatory activities associated with pipeline and late phase clinical development, working in partnership with the development R&D team and CMOs. This position reports into the SVP Regulatory Affairs and Quality Assurance. The candidate must be able to interpret biologic/ATMP regulations as they apply to given phases of drug development including preclinical, clinical and commercial. This is an exciting team-building, hands-on leadership role within the Sonoma Biotherapeutics team. The position will be based in the US in the SSF headquarters. Remote US candidates are also considered.

Roles and Responsibilities:

Proactively participate in design of global regulatory strategies for the development of cell therapy products
Oversee and manage preparation and submissions (including but not limited to protocol amendments, Initial INDs, Pre-IND/EOP meetings, CTAs, BLA/MAA, Fast Track/Breakthrough and PIPs) of high-quality regulatory according to set timelines; this will require, strong regulatory knowledge and experience, cross-functional interactions, excellent project management and writing skills, and a good understanding of the underlying science.
Interface with Regulatory counterparts (Reg CMC and Reg Ops) and collaborate with the nonclinical, clinical and CMC teams to ensure seamless strategy and integration of components in all initiatives and submissions
Participate in interactions and negotiations with regulatory agencies to clarify and solidify strategy and resolve issues
Lead preparation of agency meetings and actively participate in scheduled meetings
Drive adherence to regulatory requirements and guidelines
Perform regulatory intelligence activities – monitor regulation changes and competitor trends/strategy
Provide regulatory input regarding budget
This position requires 15-20% travel

Qualifications and Education Requirements:

BA/BS degree in life sciences – preferably in biotechnology, chemistry and/or biology. MS/PhD preferred but not required
At least 8-10 years of regulatory pharmaceutical product development experience – preferably in biotechnology, ideally in cell & gene therapy
Well-versed in regulatory strategy and regulatory science writing
Knowledgeable in ICH, FDA, EMA and WHO regulations/guidelines
Ability to work independently and thrive in a fast-paced environment
Strong attention to detail and well organized and able to multi-task
Outstanding communication and time management skills
Passionate about patient-focused drug development toward finding cures for patients in need

Sonoma Biotherapeutics remote jobs

Director, Regulatory Affairs