Director, Regulatory CMC - Cell and Gene Therapy

Regulatory Cmc Professional

Sonoma Biotherapeutics is a clinical-stage biotechnology company developing engineered regulatory T cell (Treg) therapies to treat serious autoimmune and inflammatory diseases by restoring balance to the immune system. Founded by pioneers in Treg biology and cell therapy, the company is employing proprietary platform technologies and approaches to develop a new generation of targeted and durable Treg cell therapies. Sonoma Biotherapeutics is based in South San Francisco and Seattle.

We seek an experienced Regulatory CMC professional to oversee and manage regulatory affairs activities related to CMC and manufacturing development, ultimately resulting in module 3 eCTD / IMPD filings in support of phase 1-3 clinical trials and commercial filings in the US, EU and other regions. The candidate will work in partnership with the development team and CMOs. This position reports into the SVP of Regulatory Affairs.

The candidate must be able to interpret CMC biologic / ATMP regulations and should have experience in working closely with Technical Operations, Quality Assurance and Quality Control, resulting in robust CMC strategy and filings. Significant coordination with internal cross-functional teams will be required. This is an exciting collaborative, hands-on leadership role within the Sonoma Biotherapeutics team. The position will be based in the US in SSF headquarters. Remote US candidates will also be considered.

Primary Responsibilities :

• Strong regulatory knowledge with proven track record and experience within a collaborative cross-functional environment
• Proactively collaborate with Regulatory counterparts (Clin Reg and Reg Ops) to generate regulatory strategy to support internal groups such as analytical development, QA, QC and manufacturing teams to ensure that all applicable regulatory requirements are considered and appropriately incorporated into regulatory meeting packages, IND / CTA submissions marketing authorizations in accordance with corporate goals
• Generate and manage Core Dossier, ROW applications and systems in a timely manner to meet corporate objectives. This will require strong regulatory knowledge and experience, cross-functional interactions, excellent project management and writing skills, and a solid understanding of the underlying science
• Experience in reviewing and approving technical documentation including technology transfer protocols, validation protocols, technical reports, manufacturing and labeling information to assure conformance with regulations and regulatory guidelines
• Active member of the CMC sub-team and other process development and manufacturing meetings
• Participate in interactions and negotiations with regulatory agencies to clarify and solidify strategy and resolve issues
• Drive adherence to regulatory requirements and guidelines
• Provide regulatory input regarding budget
• This position requires 15%-20% international and domestic travel

Knowledge, Education, and Skills :

Other duties :

Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice.

Equal Employment Opportunity :

At Sonoma Biotherapeutics, we believe that the highest performing teams include people from a wide variety of backgrounds and experiences who respectfully challenge each other. We are committed to building an open, diverse, and inclusive culture for all employees. Sonoma Biotherapeutics is proud to be an equal opportunity employer and does not discriminate on the basis of race, color, citizenship status, national origin, ancestry, sex, sexual orientation, age, religion, creed, physical or mental disability, medical condition, marital status, veteran status or any other characteristics protected under applicable federal, state and local laws. We've learned from experience that some of the best people don't always match our requirements perfectly - if you're interested and think you could fit, please don't hesitate to apply. Please submit your resume along with a cover letter to careers@sonomabio.com - resumes may also be submitted without applying for a specific job. If you are an individual with a disability and require a reasonable accommodation to complete any part of the application process or are limited or unable to access or use this online application process and need an alternative method for applying, please contact us at careers@sonomabio.com