Regulatory Labeling Consultant at Sangamo Therapeutics – Remote
Sangamo Therapeutics
Remote, United States
Posted on Oct 9, 2025
About This Position
Title: Regulatory Labeling Consultant
Manager: Interim Vice President, Regulatory Affairs
Department: Regulatory Affairs
Location: Remote
Sangamo Therapeutics is a genomic medicine company focused on treating debilitating neurological diseases, by using our wholly owned, highly versatile zinc finger epigenetic regulation technology and capsid delivery engine. We are passionate about designing and developing genomic medicines to transform the lives of patients suffering from severe diseases with our deep scientific expertise and proprietary zinc finger genome engineering technology. At Sangamo, we are dedicated to building a robust, sustainable genomic medicine pipeline that addresses life-limiting conditions by replacing today’s symptom-focused treatments with tomorrow’s genomic cures. 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.
JOB SUMMARY:
The Regulatory Labeling Consultant will be responsible for driving regulatory labeling strategy and execution to support ST-920 in pursuit of the accelerated approval BLA. This role requires a solid understanding of global labeling requirements and a willingness to flex between strategizing, influencing others, and rolling up your sleeves to successfully complete labeling activities. This role will work closely with Regulatory Affairs, Clinical Development, QA, CMC, and Program Teams as well as external vendors to ensure appropriate quality checks are proceduralized and implemented for all labeling activities.
Our Interim VP, Regulatory, has oversite of this role & the Regulatory Labeling Consultant will be part of cross-functional team critical to the successful filing of our first BLA. We are seeking a consummate team player with a strong leadership presence and the demonstrated ability to lead without authority to influence programs, projects, and/or initiatives.
ESSENTIAL FUNCTIONS:
Department: Regulatory Affairs
Location: Remote
Sangamo Therapeutics is a genomic medicine company focused on treating debilitating neurological diseases, by using our wholly owned, highly versatile zinc finger epigenetic regulation technology and capsid delivery engine. We are passionate about designing and developing genomic medicines to transform the lives of patients suffering from severe diseases with our deep scientific expertise and proprietary zinc finger genome engineering technology. At Sangamo, we are dedicated to building a robust, sustainable genomic medicine pipeline that addresses life-limiting conditions by replacing today’s symptom-focused treatments with tomorrow’s genomic cures. 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.
JOB SUMMARY:
The Regulatory Labeling Consultant will be responsible for driving regulatory labeling strategy and execution to support ST-920 in pursuit of the accelerated approval BLA. This role requires a solid understanding of global labeling requirements and a willingness to flex between strategizing, influencing others, and rolling up your sleeves to successfully complete labeling activities. This role will work closely with Regulatory Affairs, Clinical Development, QA, CMC, and Program Teams as well as external vendors to ensure appropriate quality checks are proceduralized and implemented for all labeling activities.
Our Interim VP, Regulatory, has oversite of this role & the Regulatory Labeling Consultant will be part of cross-functional team critical to the successful filing of our first BLA. We are seeking a consummate team player with a strong leadership presence and the demonstrated ability to lead without authority to influence programs, projects, and/or initiatives.
ESSENTIAL FUNCTIONS:
- Develop project timelines and manage labeling projects from initiation to completion.
- Provide strategic advice and guidance to cross-functional partners and stakeholders.
- Create and/or review labeling content to support the ST-920 BLA submission in accordance with FDA guidance and regulations.
- Work with vendor to develop packaging labels.
- Ensure labeling is compliant with regulations and guidances, and in line with internal SOPs for consistency across all Sangamo labels.
- If no SOP for labeling activities exist, drive development and create required SOPs and/or relevant work instructions.
- Oversee and guide Company Core Data Sheet (CCDS)/USPI review, approval, distribution and tracking. Ensure updates to the CCDS are implemented in the USAPI.
- Represent the Labeling function on the Core Teams and other cross functional teams.
- Participate in labeling negotiations with regulatory authorities.
DELIVERABLES:
Pre-BLA Submission
- Finalize labeling project timeline
- Finalize regulatory labeling content
- Vendor artwork coordination
- Ensure FDA compliance and educate program team as needed
Post-BLA Submission
- Post-marketing commitments
- Updating labeling content
- Review/approval of U.S. labelling in Structure Product Labeling (SPL) format, artwork requests, archiving labelling documents, and updating label histories.
- Performs team and/or final review of ex-U.S. labelling.
EDUCATION, EXPERIENCE AND SKILLS REQUIREMENTS:
- Bachelor’s degree with 10+ years’ relevant experience. Advanced degree, PharmD/PhD given preference.
- Significant regulatory experience in the biotech industry with 4+ years’ experience in prescription drug labeling.
- In-depth knowledge of the global labeling process, documentation, industry practice, packaging manufacturing process, and the drug development process.
- In-depth knowledge of applicable regulations and standards affecting labeling packaging, including experience developing and maintaining labeling content for major submissions.
- Experience in BLA labeling and labeling negotiations.
- Strong organizational, project management, and time management skills.
- Strong collaboration, presentation, communication, interpersonal, and leadership skills.
- Demonstrates in-depth knowledge of current global and regional trends in regulatory affairs and is able to apply this to advance and accelerate regulatory strategies for assigned products and projects.
- Advanced regulatory and business knowledge and advanced analytical abilities, as evidenced by strengths in assessing complex, multidisciplinary data, understanding and effectively advising on regulatory implications.
We believe in the value of diverse perspectives and backgrounds, and we welcome candidates who are eager to learn and contribute to our mission. We encourage you to apply even if you don’t meet all the qualifications and share what differentiates you from other candidates.
Sangamo is an equal opportunity employer
Sangamo is committed to fostering belonging for all employees and embraces diversity, equity, and inclusion in recruiting and hiring. All qualified applicants for employment are encouraged to apply and will be considered without regard to an individual’s race, color, sex, gender identity, gender expression, religion, age, national origin or ancestry, citizenship, physical or mental disability, medical condition, family care status, marital status, domestic partner status, sexual orientation, genetic information, military or veteran status, or any other basis protected by federal, state or local laws.
Pay Range
The anticipated salary range is for candidates who will work in our San Francisco Bay Area work locations. The final salary offered to a successful candidate will be dependent on several factors that may include, but are not limited to, the type and length of experience with the job, type and length of experience within the industry, education, etc. This salary range may not apply to remote positions that work in other states.
Note to External Recruiters: We do not accept unsolicited resumes from any source other than from the candidates themselves. If you wish to be considered for the presentation of candidates, please email recruiting@sangamo.com. We will reach out to you directly if there is a business need for your services.
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Job Location
Remote, United States