Senior Manager / Manager, Regulatory Affairs
Fate Therapeutics is seeking an experienced and highly motivated regulatory professional to support
its expanding cellular therapy programs. The Senior Manager / Manager, Regulatory Affairs (RA) will
provide support to the Vice President, RA in the development and implementation of regulatory
strategies for development products. This role is responsible for executing global Chemistry,
Manufacturing and Control (CMC) regulatory strategies and content plans. The primary responsibility
is to lead the CMC regulatory activities related to cellular therapies in clinical development. This role
will support CMC Teams and provide direction on the interpretation and application of global CMC
regulations and guidance related to cell therapies. This is a full-time position located at our corporate
headquarters in San Diego, CA.
• Serve as a RA CMC representative on project teams and provide regulatory expertise and input
on cross-functional team recommendations to facilitate successful product development
• Support CMC teams to develop global submission plans that comply with local regulatory
requirements and commitments.
• Author and/or lead the preparation of regulatory dossiers for submission to global Health
Authorities throughout the product lifecycle.
• Effectively and thoughtfully communicate with Health Authorities while maintaining good
rapport and credibility. When appropriate lead meetings with Health Authorities under
supervision of a senior member of the RA Department. Develop and reach consensus on
regulatory CMC strategy for Health Authority information request responses, as needed.
• Provide accurate regulatory assessments of CMC changes to project teams and refine regulatory
strategies as needed based on emerging data, therapeutic area, and evolving regulatory
• Drive a corporate culture of continuous improvement to ensure compliance with Health Authority
laws and recommendations, as well as industry best practices.
• Develop and update contingency plans for issues that may affect product registration, regulatory
compliance, and the continued lifecycle management of development products.
• Escalate issues to Regulatory Management that may affect registration, regulatory compliance
and continued lifecycle management of the product.
• May lead selected initiatives within the Regulatory Department and/or provide oversight of
• A minimum of a Bachelor of Science in biological, pharmaceutical, chemical, or engineering
sciences with generally a minimum of 3+ years of experience in the pharmaceutical or health care
industry is required. An MS, PhD, or PharmD. degree preferred.
• Experience in biologics is preferred.
• Strong knowledge of global Health Authority laws, regulations, guidance and regulation
submission routes available for assigned products is required.
• Strong experience directly writing submission documents that support clinical trials, marketing,
and lifecycle management is required.
• Experience in regulations or product development in gene therapy (i.e., CAR-Ts, AAVs, CRISPR
technology etc.) is preferred.
• Experience developing regulatory strategies and an understanding of product development, seen
as an expert on product development and how it is applied in global regulatory strategy is
• Strong attention to detail with high-level verbal and written communication skills is required;
effectively communicates cross-functionally. Ability to present and defend regulatory strategies
and opinions to project teams.
• Strong ability to quickly absorb new technical and strategic information and have the flexibility to
• High attention to detail, ability to work on multiple projects with tight deadlines, and able to work
• Demonstrates clear understanding of priorities and leads others by example to drive for results.
• Good understanding of competitors in the area and what they are doing in early/late
development is preferred.
Working Conditions and Physical Requirements
• May require occasional evening and weekend work
• Full-time onsite work at Company’s headquarters in San Diego
• May require occasional travel for training programs and meetings
The preceding job description indicates the general nature and level of work performed by employees
within this classification. Additional and incidental duties related to the primary duties may be
required from time to time.
For consideration send cover letter and resume to: email@example.com and reference job
About Fate Therapeutics, Inc.
Fate Therapeutics is a clinical-stage biopharmaceutical company dedicated to the development of
first-in-class cellular immunotherapies for cancer and immune disorders. The Company has
established a leadership position in the clinical development and manufacture of universal, off-theshelf cell products using its proprietary induced pluripotent stem cell (iPSC) product platform. The
Company’s immuno-oncology product candidates include natural killer (NK) cell and T-cell cancer
immunotherapies, which are designed to synergize with well-established cancer therapies, including
immune checkpoint inhibitors and monoclonal antibodies, and to target tumor-associated antigens
with chimeric antigen receptors (CARs). The Company’s immuno-regulatory product candidates
include ProTmune™, a pharmacologically modulated, donor cell graft that is currently being
evaluated in a Phase 2 clinical trial for the prevention of graft-versus-host disease, and a myeloidderived suppressor cell immunotherapy for promoting immune tolerance in patients with immune
disorders. Fate Therapeutics is headquartered in San Diego, CA. For more information, please
Job posted: 2020-11-05