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Director of Regulatory Affairs - San Diego, CA

Company: Kelly
Location: San Diego
Posted on: November 22, 2021

Job Description:

Regulatory Affairs Director / Senior Director Location

  • The successful candidate will already be in the San Diego area, or willing to relocate to San Diego. A portion of time may be spent telecommuting. Job Description
    • Oversees industry specific regulations, policies and procedures, and ensures all government and company regulations are being met, both in the USA and in other countries where product specific development, including clinical trials, is occurring
    • Explains such regulations, policies and procedures to company personnel
    • Ensures compliance with these regulations
    • Advises others on regulatory and compliance matters
    • Evaluates applicable laws and regulations to determine potential impact on the company
    • Creates and implements regulatory strategies for planned BLA submissions
    • Provides technical review of data and reports
    • Leads d regulatory activities related to biologics license application (BLA)
    • Coordinates regulatory documentation activities
    • Works closely with Clinical Affairs, Medical Affairs, and Manufacturing and Nonclincial colleagues to develop clinical/nonclinical, and CMC regulatory strategy
    • May supervise Regulatory Affairs team members Education and Experience
      • Minimum requirement is a Bachelor's Degree in science or healthcare. A PhD is preferred.
      • Successfully prepared and filed a BLA.
      • At least 10 years of Regulatory and/or Project Management experience. For immediate consideration apply today! Questions? Please reach out to Dustin at #TJP2021_SPEC Why Kelly -- ? Kelly-- Science & Clinical is your connection to premier scientific and clinical companies looking to hire talented people just like you. Every day, we match science professionals with dream jobs that fit their skills and interests-it's the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background/education in science, so we know a thing or two about the science market and how to get you noticed. About Kelly -- At Kelly, we're always thinking about what's next and advising job seekers on new ways of working to reach their full potential. In fact, we're a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live (plus, did we mention we provide a ton of benefits ?). Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world. Kelly is an equal opportunity employer committed to employing a diverse workforce, including, but not limited to, minorities, females, individuals with disabilities, protected veterans, sexual orientation, gender identity. Equal Employment Opportunity is The Law. ]]

Keywords: Kelly, San Diego , Director of Regulatory Affairs - San Diego, CA, Executive , San Diego, California

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