Director, CMC Regulatory Affairs (H/F)Famille de fonction : Affaires réglementaires
Description du poste et des missions
Title: Director, CMC Regulatory Affairs (H/F)
Contrat : Full-time
Location: France, Valbonne (06)
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. At Sangamo, we are passionate in developing genomic medicines to transform the lives of patients with serious diseases. We transform 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.
The Director, CMC Regulatory Affairs, will work effectively in a matrixed environment with cross-functional CMC teams, supporting multiple cell and gene therapy programs. A key focus will be to lead the development of regulatory strategies and interaction with global Health Authorities; provide strategic input and regulatory advice to the project teams on clinical and pre-clinical programs to ensure compliance with applicable regulations and health authority expectations. The successful candidate with help plan, prepare, and review regulatory documentation to ensure its suitability for submission to health authorities. If the successful candidate holds a pharmacist's degree, he could also be given the possibility to take on the role of head pharmacist for our manufacturing site.
Essential functions include, but are not limited to, the following
- Provide regulatory CMC strategic and practical hands-on support in the development of multiple innovative in vivo and ex vivo cellular gene therapy and gene editing products for the treatment of serious diseases.
- Lead and support global CMC regulatory strategies for assigned programs, in association with cross-functional teams and senior management.
- Responsible for ensuring appropriate CMC regulatory strategy to assigned project teams to ensure compliance with applicable regulations and authority expectations
- Actively seeks out knowledge of overall corporate planning and other general factors that affect the regulatory positions taken within the company, and with global health authorities, and incorporates this knowledge into submission planning
- Provides regulatory support on technical and quality activities, such as manufacturing process development, specifications, in process controls, stability protocols, and change control management, and quality and compliance initiatives
- Review clinical trial label content against country specific requirements
- Support, prepare, review, and track regulatory submission and maintenance processes to support INDs, CTAs, BLAs, MAAs to ensure compliance with ICH, as well as country specific requirements
- Lead or support interactions with regulatory health authorities
- Responsible for effective coordination efforts of multifunctional CMC disciplines for timely completion of project milestones
- Evaluate relevant global regulations and guidelines critically for their impact on development activities and regulatory plans
- Responsible for working closely and successfully with regulatory colleagues to ensure successful and timely completion of project assignments
- Evaluate proposed manufacturing changes for impact to IND/ CTA filings, and provide a regulatory assessment and a submission strategy for optimal implementation of changes
EDUCATION, EXPERIENCE AND SKILLS REQUIREMENTS:
- A Bachelor’s degree or preferably a Master’s degree in biological sciences, biotechnology, pharmacology, chemistry, or biochemical/chemical engineering.
- Minimum 10 years of experience in CMC/technical regulatory affairs. Equivalent experience across CMC regulatory and relevant biopharmaceutical development experience (e.g. Pharmaceutical Development, Analytical Development, Process Development, Quality Assurance, or Quality Control) will be considered.
- A strong scientific and technical background in biotechnology is essential and required; prior experience in cell and gene therapies is a strong asset.
- Strong knowledge of & experience with ICH, FDA and EMA drug regulations and health authority expectations.
- Fluent in English. Excellent writing and speaking skills, and ability to deliver reports and minutes.
- Ability to analyze and resolve complex regulatory problem statements.
- 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 Regulatory, Technical Operations staff (Manufacturing, Analytical and Process Development, Quality Assurance and Quality Control) and partner stakeholders.
- Known as a respectful, supportive and solution-oriented team player, with highly effective 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.
To apply, please send your resume and cover letter on our website: https://www.sangamo.com/careers/job-opportunities
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