Senior Director, Regulatory Affairs

Manager: Vice President, Global Regulatory Affairs Department: Regulatory Affairs
Location: Brisbane or Richmond

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. Using its deep scientific expertise and proprietary zinc finger genome engineering technology, Sangamo is working to create genomic cures for patients suffering from severe genetic diseases for which today's medicines can only treat symptoms. At Sangamo, we are passionate about transforming 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.

JOB SUMMARY:   
Sangamo is seeking a highly experienced Sr. Director Regulatory Affairs who will have an exciting hands-on leadership role at the forefront of innovative gene editing, gene therapy and cell therapy clinical development programs. The position will have the responsibility to lead, manage and drive regulatory activities, policy and strategy, to interface with global regulatory agencies and corporate partners, and to provide executive management with regulatory metrics and information.

ESSENTIAL FUNCTIONS: 

• Act as the recognized authority on Clinical/Nonclinical Regulatory matters
• Serve in a Regulatory leadership role to assigned clinical development project teams, providing regulatory guidance and support in global long-term clinical development planning and implementation of regulatory strategy while ensuring compliance with applicable regulations
• Work independently, directly and effectively with multifunctional disciplines (Nonclinical, Clinical, and Technical Operations) to accomplish assigned strategic and operational responsibilities related to clinical development
• Coordinate and participate in interactions with US and global regulatory authorities
• Manage the planning, preparation, and review of regulatory documentation and ensure that data and conclusions are suitable for submission to global regulatory agencies
• Manage and interface activities with potential partners and partnered programs
• Responsible for working closely and successfully with an experienced regulatory support staff to ensure orderly and timely completion of project assignments
• This is a supervisory role with direct reports. Will be required to mentor, manage and coach staff in technical and leadership areas, demonstrating leadership abilities and professionalism using excellent management skills to establish respect and accomplish goals

EDUCATION, EXPERIENCE AND SKILLS REQUIREMENTS:

• Bachelor of Science degree, preferably in biological sciences, biotechnology, pharmacology, or biochemical/chemical engineering (PhD, PharmD preferred)
• 15+ years relevant regulatory/industry experience in biotech or pharmaceutical with at least 8 years as the global Regulatory Affairs lead representative on project development teams that have led to marketing authorization
• Leadership and management experience in building high-performing teams through coaching and development
• A strong scientific and technical background in molecular biology and biologics is essential and required, experience in cell and gene therapy a very strong asset
• Strong knowledge of & experience with FDA and EU drug industry regulations and requirements, including ICH requirements and regional requirements along with an understanding of current global and regional trends in regulatory affairs and the ability to assess the impact of these requirements to the business
• Excellent writing and communication skills are critical and essential; MS Word, PowerPoint, Sharepoint, etc
• Being able to lead and record outcomes for internal management or external regulatory meetings with Health Authorities or Advisory Boards
• Must be able to work effectively, with a strategic and operational vision in a highly matrixed team-oriented structure using excellent communication, interpersonal and relationship management skills to successfully interact with Clinical, Research and Toxicology scientists, Technical Operations staff (Manufacturing, Quality Assurance and Quality Control) and corporate partner counterparts
• Demonstrated leadership experience in updating and preparing the Company for major changes in legislation and how it may impact the different functions
• Core technical/scientific expertise in nonclinical and clinical development required
• Known as a respectful, supportive and solution-oriented team player, with highly effective management, organizational and planning skills to apply daily in a multidisciplinary and matrixed environment
• Ready to embrace a culture of flexibility and innovation, patient-centric with a very high degree of urgency and commitment to translating ground-breaking science into genomic therapies that transform patients' lives
• Ability to travel, both domestically and internationally, as needed

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.   Commitment to Safety
Sangamo requires all U.S. workers to be fully vaccinated against COVID-19 as of their start date.  This requirement is a condition of employment at Sangamo, and it applies regardless of location or classification of role.  If you are unable to receive the vaccine, you will have an opportunity to request a reasonable accommodation consistent with applicable laws.    Pay Range The anticipated salary range is for candidates who will work in our Brisbane or Point Richmond, CA offices. 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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