The Senior Manager/Associate 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 and execution of regulatory strategies and interactions with global Health Authorities. The Senior Manager/Associate Director will help develop strategic input and regulatory guidance to product teams to ensure compliance with applicable regulations and health authority expectations. The successful candidate will help plan, prepare, and review regulatory documentation to ensure its suitability for submission to health authorities.
Develop, 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.
Provides regulatory support on technical and quality activities, such as manufacturing process development, specifications, in process controls, stability protocols, and change control management, and product and compliance quality initiatives.
Support the preparation of risk assessments on CMC regulatory topics.
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 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 an experienced regulatory support staff to ensure successful and timely completion of project assignments.
Evaluate proposed manufacturing changes for impact to IND/IMPD/CTA filings, and provide a regulatory assessment and a submission strategy for optimal implementation of changes.
Bachelor’s degree in biological sciences, biotechnology, pharmacology, or biochemical/chemical engineering.
5-7 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. Level will be determined by experience and skills.
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 EU drug regulations and HA expectations.
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 Regulatory, Technical Operations staff (Manufacturing, Analytical and Process Development, Quality Assurance and Quality Control) and partner stakeholders.
Known as a respectful and supportive 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, with a very high degree of urgency and commitment to translating ground-breaking science into genomic therapies that transform patients' lives.
Sangamo is an equal opportunity employer The above reflects management’s definition of essential functions for this position but does not restrict the tasks that may be assigned. The above duties are representative only; management may assign or reassign duties and responsibilities to this position at any time.
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.
Note to External Recruiters: Please understand that we do not accept unsolicited resumes from any source other than from the candidates themselves. Any agency or independent recruiter must have a signed copy of our agency agreement before presenting candidates. Submission of unsolicited resumes without our signed agreement will not create any implied obligation on our part.
If you wish to be considered for the presentation of candidates, please contact us through Recruiting@sangamo.com. Attach your contact information, your area of specialty, and any marketing information you wish to provide. Someone form the Talent Acquisition Department will contact you directly if there is a business need for your services.
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.