Job Description

Fate Therapeutics is looking for an Executive Director or Senior Director in Regulatory Affairs to oversee and direct the strategic planning and execution of clinical regulatory activities essential for initiating and conducting clinical trials and securing regulatory approvals. This role involves extensive interaction with regulatory agencies such as the FDA and EMA and provides cross-functional leadership for global filings. The ideal candidate will have extensive experience leading regulatory teams and a successful record of approved regulatory submissions. This is a full-time, exempt position located at our corporate headquarters in San Diego, CA. Responsibilities

• Lead the Regulatory Affairs team in effectively working with internal and external stakeholders to independently manage clinical regulatory activities.
• Set strategy, direct, plan and implement clinical regulatory activities required to initiate and conduct clinical trials and to seek marketing authorization.
• Provide strong cross-functional leadership for global filings including authoring/reviewing sections of IND/CTA, NDA/BLA/MAA, and other global submission documents in support of clinical trials and marketing applications, as well as their amendments, in conformance with local regulatory requirements.
• Lead regulatory strategy and activities for pivotal and registrational studies.
• Develop and implement cross-functional department policies, processes, work instructions, and standard operating procedures.
• Provide regulatory leadership for due diligence activities, partnering activities, and product/company integrations.
• Provide mentorship and oversight of Regulatory Affairs staff to plan, manage, author, coordinate, and review regulatory submission documents and development activities to support regulatory filings and dossier lifecycle.
• Work with the clinical team to provide regulatory input on clinical study protocols, ICFs, SAPs, and CSRs.
• Apply regulations and Health Authority guidance to provide regulatory strategic leadership to cross-functional stakeholders, including clinical development, clinical operations, and patient safety.
• Serve as a Regulatory Affairs representative in cross-functional meetings and interact with external collaborators.
• Establish functional processes, guidelines, and SOP’s.
• Create the strategy and lead preparation of health authority meeting materials and responses to requests for information.
• Lead preparations of ex-US filings and health authority interactions.
• Serve as primary contact with regulatory authorities.
• Develop and implement departmental strategies, policies, and regulatory risk management.
• Assure compliance with all applicable domestic and international regulations.
• May oversee direct reports, contractors, and/or vendors.
• Inspire, influence, and motivate team members, foster open communication, set clear goals, delegate tasks, and monitor performance.

• BS/MS/PhD degree in a life science with at least 12 years of progressive experience in Regulatory Affairs in the biotechnology or pharmaceutical industry.
• Demonstrated direct experience with Health Authority submissions and strong knowledge of FDA/EMA/MHRA regulations and agency submission and approval processes.
• Proven experience in applying regulatory knowledge to various clinical activities; strong knowledge of clinical study design, Good Clinical Practice principles, and navigation of clinical development pathways.
• Strong knowledge of the regulatory requirements for a variety of clinical regulatory documents (protocols, ICFs, CSRs, etc.).
• In-depth knowledge of various clinical areas (clinical development, clinical operations, safety, etc.).
• Strong ability to quickly absorb new technical and strategic information and have the flexibility to adapt accordingly.
• Excellent operational skills including planning, organizing, and the ability to deal effectively with a variety of personnel both internally and outside the company to drive projects to timely completion.
• Excellent writing, communication, and interpretive skills.
• High attention to detail, ability to work on multiple projects with tight deadlines and able to work independently.
• Experience leading regulatory activities for pivotal / registrational studies is highly preferred.
• Previous cell therapy product experience and regulatory knowledge is highly preferred.
• Prior direct interactions with Health Authorities are desirable.
• Prior participation in a GCP inspection is desirable.
• Experience with CTA filing preferred.
• Experience leading and managing regulatory affairs teams.

• Travel may be required.
• Subject to extended periods of sitting and standing, vision to monitor, and moderate noise levels.

• The salary offer will be based on a variety of factors, including level, experience, qualifications, internal equity, and location.
• Fate offers a competitive employment package that includes an annual bonus, equity, and a generous benefits package.
• The anticipated salary range for this role is $255,000 - $315,000.

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.

Equal Employment Opportunity

Fate Therapeutics, Inc. is an equal opportunity employer. We value diversity and are committed to creating an inclusive environment for all employees.

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