Associate Director, Regulatory Affairs
Manager: Vice President, Global Regulatory Affairs
Location: Richmond, CA or Brisbane, CA
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.
The Associate Director, Regulatory Affairs, will be responsible for managing regulatory affairs activities for assigned clinical development programs from preclinical candidate designation through drug approval, including regulatory submissions, such as original INDs & CTAs, amendments/annual reports, GMO applications, and relevant quality documents. Responsibilities include timely planning and coordinating of regulatory submissions, providing support to cross-functional teams on regulatory strategy, working with project teams, assisting on authoring and managing regulatory submissions, archiving and submission tracking. This individual will be responsible for maintaining an in-depth awareness of relevant FDA and EU regulations and policies to optimize regulatory input to assigned projects and teams.
- Represent Regulatory for 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, drafting and review of regulatory documentation, including IND/CTA/GMO/BLA/MAA, regulatory interactions, responses to queries from competent authorities, as required for investigational and registration of drugs in the US and ex-US countries.
- Collaborate on submission content with contributing authors across functional areas to achieve regulatory compliance and ensure data and conclusions are suitable for submission to regulatory agencies.
- Manage/track regulatory submission documents and timelines, collaborating with Clinical Operations and CROs to ensure timely submissions of all deliverables.
- Provide expertise in translating local, regional, and international regulatory requirements into workable plans with cross-functional teams.
- Assist in the preparation of regulatory-related meetings such as Advisory Boards and Scientific Advice and to prepare draft meeting minutes.
- Contribute to the identification and assessment of relevant news and guidance in order to inform Sangamo of potential impact (i.e. Regulatory Intelligence)
- Maintain up-to-date knowledge of current regulations for applicable territories.
- Contribute to the development and maintenance of Regulatory Affairs Department working practices and procedures.
- Other tasks and responsibilities as directed by the Regulatory Affairs leadership team.
EDUCATION, EXPERIENCE AND SKILLS REQUIREMENTS:
- Bachelor's Degree in pharmacy, biology, chemistry, pharmacology, or related subject. A relevant master’s degree is preferred.
- 7-10 years in R&D or related area. Should include 5 years in Regulatory Affairs.
- Strong organizational skills and ability to work on several projects in alignment with timelines.
- Strong verbal and written communication skills and interpersonal skills.
- Strong collaboration / teamwork skills to efficiently work in a cross-functional environment.
- Must be able to effectively identify data needs, and successfully present to management.
- Understanding of regulatory requirements, including ICH requirements and regional requirements for assigned territories.
- Is recognized as a knowledgeable resource within the department on focused topics.
- Work is performed under minimal supervision of a Regulatory Affairs professional.
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 from the Talent Acquisition Department will contact you directly if there is a business need for your services.