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Director/Senior Director, Regulatory Affairs

JOB SUMMARY:    Sangamo is seeking a highly experienced Director/ Sr. Director Regulatory Affairs who will have an exciting hands-on leadership role at the forefront of innovative gene editing and cell and gene therapy clinical development programs.  The position will have the responsibility to lead, manage and drive regulatory activities, policy and strategy, to interface with regulatory agencies and corporate partners, and to provide executive management with regulatory metrics and information.  The position will share responsibility for coordination and management of regulatory affairs activities related to global product development with our new locations in Europe.   ESSENTIAL FUNCTIONS: Support VP, Regulatory and Sangamo Program Development as follows:  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 Play a key role in planning, preparation, and review of regulatory documentation and ensure data and conclusions are suitable for submission to regulatory agencies Work independently, directly and effectively with multifunctional disciplines (Preclinical, 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 Be a strong and supportive team player.  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 Be proficient in 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      EDUCATION, EXPERIENCE AND SKILLS REQUIREMENTS: Bachelor's degreerequired, preferably in biological sciences Minimum of 12 - 15 years relevant experience in biotech or pharmaceutical regulatory affairs and clinical 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 Excellent writing and editing skills are critical and essential; MS Word, PowerPoint, etc Must be able to work effectively in a highly matrixed team-oriented structure using excellent communication, interpersonal and relationship management skills to successfully interact with Clinical Operations, Research scientists, Technical Operations staff (Manufacturing, Quality Assurance and Quality Control) and corporate partner counterparts Core technical/scientific expertise in preclinical and clinical development required Known as a respectful and supportive 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, 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.
Salary Range: NA
Minimum Qualification
11 - 15 years

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