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Manager, CMC Regulatory Affairs

Company: Kelly Services
Location: Bothell
Posted on: April 9, 2021

Job Description:

Kelly Science and Clinical is the world's most recognized brand in science and clinical staffing with more than 100 locations in North America, Europe, and the Pacific Rim. Our scientists contribute to the research and development of the next generation of small molecule drugs, biologics and cellular therapies.OverviewWe are seeking a Senior Specialist/Manager, Regulatory Affairs CMC, or one of our clients, a commercial-stage biopharmaceutical company committed to discovering, developing and commercializing small-molecule and protein therapeutics for a wide variety of disorders. The incumbent will be primarily responsible for the preparation, review, and compilation of CMC filings in support of commercial and clinical applications in accordance with ICH requirements, regional requirements, and scientific and company policies and procedures. Performs a wide variety of activities to ensure compliance with applicable GxP and other regulatory requirements.Responsibilities--

  • Prepare content of CMC documentation for large and small molecule product submissions to regulatory agencies (FDA/EMA), ensuring accuracy, completeness, and consistency with strategy
  • Review and edit final documents for regulatory CMC submissions in a timely manner
  • Prepare information and related activities for CMC meetings with health authorities
  • Stay up to date on knowledge of regulatory requirements, including CMC and general regulatory, and communicates changes in regulatory information to full regulatory team as well as project teams in a timely manner
  • Maintain current awareness of evolving regulatory environment including advisory letters, enforcement letters and policy issues
  • Participate, as needed, in local and/or global submission process to assist in the overall efficiency of the regulatory submission process
  • Manage regulatory CMC activities within time and budget for approved project plans
  • Help define and implement strategic regulatory CMC activities across programsQualifications
    • A bachelor's degree in scientific discipline, master's degree preferred, plus training in regulatory affairs
    • For the Sr. Specialist level you will need 5+ years of experience in the pharmaceutical industry with a minimum of 2 years of experience in CMC regulatory, including working on biologics; for the Manager level, you will need 5 - 8 years of experience in a related discipline with a minimum of 3 years in CMC including working on biologics
    • A solid understanding of CMC regulatory requirements including FDA and ICH guidelines for large and small molecule products as they apply to post-approval changes to marketed products as well as the registration, development, and approval of investigational products
    • Demonstrated ability to build and maintain positive relationships with management, peers, and subordinates
    • Demonstrated ability to work with a cross functional team as well as independently
    • Highly detail-oriented, well-organized, and able to prioritize multiple tasks to meet deadlines
    • Strong interpersonal and communication skills, both verbal and written
    • Strong analytical and problem-solving skills
    • Strong work ethic
    • Computer application skills: Advanced MS Office, Adobe Acrobat#TJP2021_SPECWhy 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. 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 Services, Seattle , Manager, CMC Regulatory Affairs, Executive , Bothell, Washington

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