Regulatory Affairs Manager – Cell & Gene Therapy (CGT)

Regulatory/Compliance | Santa Ana, CA

Job Function:

We are hiring a Regulatory Affairs Manager – Cell & Gene Therapy (CGT). The Regulatory Affairs Manager – CGT will provide regulatory support and expertise for Cell and Gene Therapy (CGT) and Bioproduction (BP) product lines. The person in this role will ensure that product, process, and procedures are sufficiently controlled to assure the quality of products and compliance. The Regulatory Affairs Manager will also assist and provide support to customers with their regulatory submissions as needed. This person will also ensure that requirements are met in all regulatory functions as applicable to CGT and BP products by the FDA’s GMPs (QSR), ISO 13485, Health Canada and related cell and gene therapy product line requirements in all countries where product is distributed. 

Job Duties:

  • Ensure compliance of all processes and procedures to applicable standards
  • Communicate with regulatory agencies, notified bodies, and competent authorities
  • Oversee, manage and assist with the following activities:
    • Writing and/or revising CGT related standard operating procedures
    • Review and approval of scientific data generated to support claims, warnings and precaution of products
    • Review promotional items and frequently asked questions (FAQ) and answers
    • Support Internal/External and Customer Audits, as it relates to C&GT and associated product lines as needed
    • Assist with changes to product design, specifications, or product manufacturing processes
    • Member of the New Product Design Control for CGT and BP products
    • Product Recalls
    • Field safety corrections
    • Mandatory Device Reporting (MDR)
    • Mandatory Problem Reporting (MPR)
    • Vigilance Reporting (EU)
    • Adverse Events Reporting (Worldwide)
  • Provide regulatory approval for CGT and BP related activities, but not limited to:
    • Non-conformances
    • CAPA
    • Quality Planning
    • Risk Assessments
    • Document Changes (SOPs, labeling, etc.)
  • Support customers with their regulatory filings and provide technical support as needed
  • Manage, create, and monitor Drug Master Filings for US FDA, Japan PMDA and ROW, as needed
  • Assist in the assessment of Technical Department (R&D) activities that include, but are not limited to, the following:
    • Risk Management File Review and revision based upon complaint
  • Assist in the identification of, but not limited to, the following:
    • Relevant guidance documents, international standards, or consensus standards and their interpretation as they relate to product lines
  • Notification to management of new and revised documents referenced above

Experience/Education:

  • Bachelor’s degree in Microbiology, Biology, or Chemistry preferred
  • Five (5) years’ experience in Quality Assurance/Quality Control/Regulatory Affairs in a medical device discipline; experience in stem cell, cell and tissue field preferable from education or industry
  • 2+ years of supervisory experience
  • Knowledge of Cell and Gene Therapy requirements worldwide for Ancillary Materials and Therapies supported by FUJIFILM Irvine Scientific
  • Thoroughly knowledgeable in requirements of GMPs, CFRs, USP, ISO 13485, CMDR
  • Knowledge of Quality Control Methodology, QA control systems and production methodologies
  • Ability to interpret regulatory standards, guidance and laws
  • Experience in Regulatory Affairs and compliance
  • Ability to work with team members and lead cross functional teams
  • Experience with risk management and Failure Mode Effects Analysis (FMEA)

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Principals only. No recruiters please.

FUJIFILM Irvine Scientific is an equal opportunity employer. All qualified candidates will receive consideration for employment without regard to race, color, religion, sex including sexual orientation and gender identity, national origin, disability, protected Veteran status, or any other characteristic protected by applicable federal, state, or local law.

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