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Director, Regulatory Affairs

Company: Kelly
Location: Redwood City
Posted on: May 2, 2021

Job Description:

Director, Regulatory Affairs Company Overview: Pursuing the development of both oligonucleotide-based and small molecule therapeutics, with the goal of becoming a world leader in the development of targeted, antiviral therapies for CHB and COVID-19 and to leverage our expertise in other disease areas as well. Our science is the key to our success, and to improving patients' quality of life. Our pipeline of developing novel compounds and investigative therapies reflects our commitment to bring innovative products to patients with unmet needs in the area of liver diseases. This is an exciting opportunity to become an early employee of a high energy, Research and Development company. We are looking for an enthusiastic professional who understands and appreciates the entrepreneurial environment of a "start-up" and who is willing to do what it takes to contribute to the success of the company. Position Summary: The Director, Regulatory Affairs will report directly to the Head of Clinical Development and will be responsible for providing regulatory leadership and support for therapeutics development programs. This is a highly visible role that interacts with a broad range of functions within an early drug development environment at a small dynamic biotech company. As this is a new role, there is an exciting opportunity to help define and evolve this function. Essential Functions / Responsibilities: Key responsibilities include:

  • Providing strategic regulatory input for each compound development plan to ensure programs advance efficiently
  • Leading and working closely with project team members to generate regulatory documents that are required for worldwide submissions and coordination of such activities within the company
  • Identification of potential program level regulatory risks and development of mitigation strategies
  • Management of global strategic regulatory interactions, including development of relevant supporting documentation
  • Oversight of study related regulatory interactions, including CTA submissions and responses to questions from regulatory agencies
  • Coordination of meetings with regulatory agencies
  • Oversight of external regulatory service providers and consultants Reasonable accommodations may be made to enable individuals with disabilities to perform these essential functions. Required Education and Experience:
    • BS/MS Degree with 10+ years of relevant progressive regulatory affairs management experience in the drug development
    • Demonstrated experience in the biotech/pharmaceutical industry including an ability to manage in a matrixed project team environment including coordination of all cross-functional aspects of drug development (e.g., preclinical, CMC, regulatory, clinical, quality, etc.) to achieve regulatory filing goals.
    • Experience leading meetings and teleconferences with regulatory agencies
    • High level of oral and written communication proficiency
    • Evidence of strong critical, strategic, and analytical thinking skills
    • Demonstrated record of accomplishment; proven track record of coordinating and authoring regulatory documents Preferred Education and Experience:
      • Experience in antiviral drug development desired but not essential Additional Eligibility Qualifications/Competencies
        • Excellent interpersonal and communications skills, ability to build productive internal/external working relationships with cross-functional teams
        • The successful candidate must be flexible and adaptable to the needs of a small company. Work Authorization/Security Clearance
          • All candidates are expected to have authorization to work in the United States. Supervisory Responsibility
            • Initially, no direct line management responsibility.
            • Will provide oversight of vendors and service providers Position Type and Expected Hours of Work
              • This is a full-time position. Expected days and hours of work are Monday through Friday, 40 hours per week. Physical Requirements
                • It is expected that the employee is able to sit / stand at a desk and have full use of a computer through its standard input devices (e.g., mouse and keyboard). Travel
                  • This position is located in South San Francisco, CA and may require approximately 5% travel 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, Redwood City , Director, Regulatory Affairs, Executive , Redwood City, California

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