Associate Director, Regulatory Affairs
Company: Public Affairs Council
Location: San Diego
Posted on: January 14, 2021
357JB, Associate Director, Regulatory Affairs Fate Therapeutics
Fate Therapeutics is seeking an experienced and highly motivated
regulatory professional to
support its expanding cellular therapy programs. The Associate
Director, Regulatory Affairs (RA)
will provide support to the Vice President, RA in the development
and implementation of
regulatory strategies for development products. The Associate
Director, RA is responsible for
developing 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. The Associate Director 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, reporting to the VP, Regulatory Affairs.
--- Serve as the RA CMC Lead on project teams and provide
regulatory expertise and input on
cross-functional team recommendations to facilitate successful
--- Lead 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
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
--- Drive a corporate culture of continuous improvement to ensure
compliance with Health
Authority laws and recommendations, as well as industry best
--- Develop and update contingency plans for issues that may affect
regulatory compliance, and the continued lifecycle management of
--- Escalate issues to Regulatory Management that may affect
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 7+ years of experience
inclusive of post graduate
education and/or pharmaceutical or health care industry experience
or equivalent 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
--- Strong attention to detail with high-level verbal and written
communication skills is required;
effectively communicates cross-functionally. Ability to present and
strategies and opinions to project teams.
--- Strong ability to quickly absorb new technical and strategic
information and have the
flexibility to adapt accordingly.
--- High attention to detail, ability to work on multiple projects
with tight deadlines, and able to
--- Demonstrates clear understanding of priorities and leads others
by example to drive for
--- 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
--- May require occasional travel for training programs and
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
About Fate Therapeutics, Inc.
Fate Therapeutics is a clinical-stage biopharmaceutical company
dedicated to the development of firstin-class cellular
immunotherapies for cancer and immune disorders. The Company has
leadership position in the clinical development and manufacture of
universal, off-the-shelf cell products
using its proprietary induced pluripotent stem cell (iPSC) product
platform. The Company's immunooncology product candidates include
natural killer (NK) cell and T-cell cancer immunotherapies,
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
myeloid-derived suppressor cell immunotherapy
for promoting immune tolerance in patients with immune disorders.
Fate Therapeutics is headquartered
in San Diego, CA. For more information, please visit
Keywords: Public Affairs Council, San Diego , Associate Director, Regulatory Affairs, Executive , San Diego, California
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