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Senior Manager, Regulatory Affairs CMC

Fate Therapeutics, Inc.

San Diego, CA Full-time Posted 3d ago
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Fate Therapeutics is looking for Senior Manager, Regulatory Affairs CMC to help advance innovative cell therapy products from early development through licensure. In this role, you will shape global CMC regulatory strategy, lead high-quality submissions, partner across technical and quality teams, and contribute to health authority interactions. The ideal candidate is a collaborative regulatory professional with strong CMC expertise, biotechnology or pharmaceutical experience, sound judgment, and the communication skills to influence cross-functional teams in a fast-paced, mission-driven environment.This is a full-time, exempt position located at our corporate headquarters in San Diego, CA. RESPONSIBILITIES Serve as the Regulatory Affairs CMC lead on cross-functional project teams, providing global regulatory guidance to support successful product development. Develop and execute Regulatory CMC strategies for cell therapy products from early development through licensure. Lead preparation and review of CMC submission documents and dossiers for global health authorities, including briefing packages and IND, IMPD, BLA, and MAA filings. Author and lead responses to health authority CMC-related queries in collaboration with relevant functions. Partner with CMC, analytical, process, quality, research, and regulatory teams to deliver high-quality submissions and query responses. Provide regulatory assessments for CMC changes through change control activities. Track regulatory CMC commitments to health authorities. Support product and package labeling maintenance to meet global regulatory requirements. Monitor and interpret current and emerging global regulations, guidelines, and precedents relevant to the company’s products and therapeutic areas to support compliance and continuous improvement. Develop and maintain contingency plans for issues affecting product registration, regulatory compliance, or lifecycle management. Proactively identify, assess, and escalate CMC regulatory issues and risks; develop mitigation strategies across FATE’s product pipeline. Contribute to continuous improvement of Regulatory Affairs processes, templates, and best practices to enhance quality, efficiency, and compliance. QUALIFICATIONS Bachelor’s degree in biological, pharmaceutical, chemical, or engineering sciences required; advanced degree (M.S., Ph.D., or Pharm.D.) preferred. Minimum 7 years of progressive Regulatory Affairs or other relevant CMC experience in the pharmaceutical or biotechnology industry. Strong knowledge of global health authority regulations, guidelines, and submission pathways. Demonstrated success leading regulatory submissions and documentation. Experience with biologics and/or cell and gene therapies, such as CAR-T, AAV, or CRISPR, preferred. Experience with Veeva Vault RIM and QMS systems a plus. Excellent verbal and written communication skills, including the ability to present and defend regulatory strategies cross-functionally. Exceptional attention to detail, organizational skills, and ability to manage multiple priorities under tight deadlines. Adaptable, with the ability to quickly absorb and apply new technical and strategic information. WORKING CONDITIONS & PHYSICAL REQUIREMENTS Occasional travel may be required (up to 10%). Subject to extended periods of sitting and standing, vision to monitor, and moderate noise levels. COMPENSATION 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 $160,000 - $190,000. 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. Privacy Notice To learn about how Fate collects and uses job application information, please visit Fate's online Privacy Notice. About Fate Therapeutics, Inc. Fate Therapeutics is a clinical-stage biopharmaceutical company dedicated to bringing a pipeline of induced pluripotent stem cell (iPSC)-derived cellular immunotherapies to patients. Using its proprietary iPSC product platform, the Company has established a leadership position in creating multiplexed-engineered master iPSC lines and in the manufacture and clinical development of off-the-shelf, iPSC-derived cell products. The Company’s pipeline includes iPSC-derived T-cell and natural killer (NK) cell product candidates, which are selectively designed, incorporate novel synthetic controls of cell function, and are intended to deliver multiple therapeutic mechanisms to patients. Fate Therapeutics is headquartered in San Diego, CA. For more information, please visit www.fatetherapeutics.com. ⚠️ Recruitment Fraud Alert   Recently, we have been made aware of unauthorized individuals falsely presenting themselves as Fate Therapeutics employees or recruiters as part of online scams or phishing attempts. Impersonators may use the Fate Therapeutics name and logo, as well as employee names and job titles, to gain a job seeker’s personal or banking information or to request payment as a condition of being considered for a position at the company. Fate Therapeutics and its employees are not involved in these scams.   Here are a few things to be aware of to help identify recruitment fraud: - Our Talent Acquisition team only corresponds from our @fatetherapeutics.com domain. - At no stage in our hiring process will we require payment or ask you to make deposits in your bank account. - We will only ask for personal information when applying for a position via our Careers page or thereafter. - At no stage during our hiring process will we ask you to click a link to begin a one-way video interview. - We do not use Google Hangouts, WhatsApp, or other third-party messaging platforms to recruit candidates or conduct interviews.   Please exercise caution. If something feels off about your interactions, we encourage you to contact us at [email protected] to confirm the authenticity of the message. Your security is important to us, and we appreciate your vigilance.

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