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Regulatory Affairs/Quality Assurance Specialist

Company Name: Invitrx Therapeutics Inc.
Location: Lake Forest, CA
Job Type: Full Time
Contact Name: Mehrzad Mirzaei Fattahi
Email:  This email address is being protected from spambots. You need JavaScript enabled to view it.
Salary: DOE

Job Description

Cell therapy company looking for a Regulatory Affairs/Quality Assurance Specialist who possesses a deep understanding of international, federal and state regulations.

Responsibilities (include but are not limited to):

  • File IND, BLA, and other applications as necessary

  • Maintain licenses and registrations

  • Develop and maintain a positive working rapport with the regulatory agencies

  • Develop, implement and maintain standard operating procedures and quality management system

  • Management of data review, analysis, identification of trends, and complex problem solving.

  • Manage problems of diverse scope using a high degree of judgment and risk-based decision making.

  • Track and trend quality system performance, providing periodic updates to Management Review and approve deviations, CAPA, and Change Control, performing Failure Mode and Effect Analyses, root cause analyses, and CAPA effectiveness check as required.

  • Manage and lead efforts related to Internal audits.

  • Provide support for site visits or audits conducted by clients or regulatory/accrediting agencies.

  • Interpret regulations and ensure compliance to departmental policies and procedures.

  • Maintain current knowledge of relevant regulations, including proposed and final rules



Job Requirements

Qualifications

  • Bachelor’s Degree with 3 years of relevant US regulatory (FDA) / drug development experience

  • Knowledge of cGMP manufacturing and regulations (21 CFR 210, 211)

  • Must have previous experience with IND and BLA submissions

  • Background in AABB or AATB experience is preferred

  • Cell Therapy Experience is a plus

  • Must have excellent attention to detail, project and time management skills

  • Ability to manage multiple competing priorities with aggressive timelines  

  • Excellent interpersonal, verbal and written communication skills are essential in this collaborative work environment

  • Must be proficient in Microsoft Word, Excel, Outlook and PowerPoint.

  • Strong attention to detail and ability to maintain project deadlines

  • High energy level and a positive outlook coupled with the requisite “can do” attitude

  • Willingness to do what it takes to achieve personal and organizational goals and overcome obstacles

  • Able to think outside of the box and adapt best practices to our small, but growing environment

  • Self-motivated with a strong sense of ownership in areas of responsibility

  • High degree of professionalism, ethics and integrity

  • Comfortable in a fast-paced small company environment with minimal direction and able to adjust workload based upon changing priorities