Temporary Regulatory Affairs Operations Senior Specialist

Title: Temporary Regulatory Affairs Operations Senior Specialist

Manager: Senior Director, Regulatory Affairs

Department: Regulatory Affairs

Location: Richmond, CA or Remote (US Only & in Pacific time zone)

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:

We are seeking a temporary Regulatory Affairs Operations Senior Specialist to join our team, ensuring Sangamo meets US and EU regulatory submission requirements. The successful candidate will be responsible for coordination, preparation, tracking and filing of document packages for regulatory submission from all areas of research and development.

This is a temporary position.

We are only considering candidates in the Pacific time zone who currently reside in the United States.

Visa sponsership is not available for this role.

ESSENTIAL FUNCTIONS:

• Preparation, coordination, compilation, formatting, and filing of global regulatory submissions, including INDs, CTAs, BLAs, Drug Master Files, DSURs, Meeting Materials and IND amendments providing for changes in the clinical program and manufacture of the product.
• Understand electronic common technical document (eCTD) submission requirements in both the US and EU and interface closely with publishing vendor(s) to process, validate and approve eCTD submissions
• Maintain/archive all regulatory submissions and correspondence for company sponsored projects, and all company related sections for partner sponsored projects.
• Responsible for business administration of Regulatory systems (SharePoint, InSight Publisher/Viewer and Veeva Vault RIM), including (but not limited to) user management, training, issue escalation and resolution and working with IT and third-party providers.
• Maintain up-to-date knowledge of global standards and procedures for regulatory submissions and publishing standards, including eCTD and CTA; analyze new guidance documents and requirements related to electronic submissions, and recommend courses of action.
• Prepare special reports and assemble documentation to support department activities as needed
• Identify process improvements and automation opportunities to increase operational efficiency while ensuring submission integrity.
• Ensure that issues are identified at an early date and actively contribute to issue resolution before filing dates are impacted.
  
  
  

EDUCATION, EXPERIENCE AND SKILLS REQUIREMENTS:

• Bachelor's degree, preferably in a scientific/technical discipline, or equivalent work experience
• 3+ years of regulatory operations experience
• Excellent document formatting and publishing skills using the following applications: MS Word (particular emphasis on document formatting), Adobe Acrobat, PowerPoint and Excel
• Experience in eCTD filings
• Experience in European Regulatory submission policies and practices
• Excellent and hands-on experience in technologies such as SharePoint, eCTD Publishing Tools (InSight Publisher/Viewer), Veeva Vault RIM, and off-the shelf and plug-in software such as DXC Toolbox that supports Regulatory publishing
• Detail-oriented with a capacity to deliver accurate results.
• Able to execute operational processes and quality process checks that ensure regulatory compliance.
• Flexibility to work effectively within an environment with quickly changing processes, priorities, and deadlines and have strong problem-solving skills regarding streamlining non-routine problems in relation to department procedures and processes.
• 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
  
  
  

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.