Regulatory Jobs
Hero Gradient Background
Fate Therapeutics logo

New · posted Oct 15

Fate Therapeutics · Biotechnology

Senior Manager, Regulatory Affairs CMC

  • San Diego, CA
  • On-site
  • Full-time
  • Manager
Save
Pay$160K–$190Ka year · employer provided
EmploymentFull-time
LocationSan Diego, CAOn-site
LevelManager
FunctionRegulatory CMCRegulatory
Deadline

Open until filled

The role

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.

What you need

  • 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.

    • Skills named in this posting

    What you'll do

  • 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.

    • Pay and benefits

    $160,000 – $190,000 a year

    Employer provided
    How this compares

  • 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.

    • Annual bonus

    • Equity

    • Generous benefits package

    Where you'll work

    San Diego, CAOn-siteOpen in Maps (opens in a new tab)

    More jobs in San Diego, CA
    Equal opportunity, accessibility and legal noticesFate Therapeutics's statements, word for word

    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.

    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.

    Job intelligence

    The context around this role

    Live data · October 15, 2026

    Salary intelligence

    How the pay compares

    This role's midpoint is 2% above the US median for Regulatory CMC roles at this level.

    This roleEmployer provided

    $160,000 to $190,000 a year

    Manager roles in California10 roles publishing pay

    Middle half $162,125 to $179,125, median $167,500

    Manager roles in the US15 roles publishing pay

    Middle half $157,000 to $180,750, median $171,000
    Annual base pay
    Annual base payLowMedianHigh
    This role$160,000—$190,000
    California$162,125$167,500$179,125
    All US$157,000$171,000$180,750

    This role: Fate Therapeutics's own published range. Comparisons: the base pay employers published on open Regulatory CMC roles at the same level on Regulatory Jobs, October 15, 2026. Nothing is estimated.

    Career trajectory

    Where this role sits in Regulatory CMC

    The general path across 82 open Regulatory CMC roles on Regulatory Jobs, with the titles they carry most. Not Fate Therapeutics's own promotion track.

    1. Earlier

      Associate & Specialist

      Often: Intern · Associate CMC Regulatory Sciences Data Analyst

      $77K median8 open

    2. One step back

      Senior & Principal

      Often: Advisor/Sr. Advisor · Global Regulatory CMC Lead

      $155K median8 open

    3. This role

      Manager

      Often: Manager, CMC Regulatory Affairs · Manager, Regulatory Affairs CMC

      $171K median17 open

    4. Next step

      Director

      Often: Director, Global Regulatory Affairs · Director, Regulatory CMC

      $210K median45 open

    5. Later

      VP & Executive

      Often: Global Head of Technical Regulatory & Quality · Head of CMC Regulatory Affairs

      4 open

    Career resources on Regulatory CMC

    Skills DNA

    What this role leans on

    How many of the posting's 4 duty, requirement and summary lines touch each area. The posting's emphasis, not a proficiency score.

    GMP and compliance: 2 linesLab testing and methods: 1 lineDocumentation and SOPs: 2 linesRegulatory submissions: 3 linesQuality systems and risk: 2 linesData and digital systems: 1 lineCollaboration and leadership: 3 linesGMPLab testingDocumentationSubmissionsQuality systemsData systemsTeamwork
    • Regulatory submissions3
    • Collaboration and leadership3
    • GMP and compliance2
    • Documentation and SOPs2
    • Quality systems and risk2
    • Lab testing and methods1
    • Data and digital systems1

    Regulatory intelligence

    The rules behind this role

    Frameworks and standards this posting's work falls under, matched from its own words, each linked to the official source.

    From Regulatory News

    Manufacturing and quality coverage for this profession

    Company hiring pulse

    Fate Therapeutics on Regulatory Jobs

    2
    Open roles
    2
    Distinct roles
    1
    Locations
    See all 2 Fate Therapeutics roles

    More roles at Fate Therapeutics

    Similar Regulatory CMC roles elsewhere

    Senior Manager, Regulatory Affairs CMC at Fate Therapeutics

    Open until filled. $160K–$190K a year, employer provided.

    Job alerts
      Senior Manager, Regulatory Affairs CMC at Fate Therapeutics — San Diego, CA | Regulatory Jobs