Jobs
>
Fairfield

    Vice President/Senior Vice President, Regulatory Affairs - Fairfield, United States - Meet Recruitment

    Default job background
    Description
    Vice President/Senior Vice President, Regulatory Affairs

    This range is provided by Meet. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more.
    Vice President or Senior Vice President, Regulatory Affairs & Quality Assurance

    Meet has engaged on a search for a confidential search for a VP/SVP of Regulatory and Quality with one of our biotech clients.

    Our client is focused in the Heme/Onc space - you'll be reporting into C-Suite and will be heading up Reg and Quality for the organization.

    Additional details can be provided via phone call.
    Key Responsibilities
    Lead Regulatory Affairs and Quality Assurance functions
    Manage all aspects of Regulatory submissions (IND/CTA, NDA/BLA/MAA)
    Manage FDA (and ex-US Health Authority) interactions
    Key Qualifications
    20+ years of industry experience, minimum 10 years of management/leadership experience
    Oncology experience required
    Full development cycle experience required (pre-IND through commercial)
    Startup experience highly preferred
    Please reach out to Ryan Moran to setup a confidential conversation:

    :

    Seniority level

    Seniority level

    Executive
    Employment type

    Employment type

    Full-time
    Job function

    Job function

    Strategy/Planning, Writing/Editing, and Science
    Industries

    Biotechnology Research and Pharmaceutical Manufacturing
    Referrals increase your chances of interviewing at Meet by 2x
    Get notified about new

    Vice President Regulatory Affairs

    jobs in

    San Francisco Bay Area .
    San Francisco Bay Area

    $200,000 - $300,000

    3 weeks ago
    San Jose, CA

    $243,720 - $278,724

    1 week ago
    Daly City, CA

    $230,000 - $250,000

    3 weeks ago
    San Francisco, CA

    $220,000 - $300,000

    3 weeks ago
    VP, Associate General Counsel, Corporate Legal

    San Jose, CA

    $229,400 - $471,500

    1 month ago
    Vice President, Head of Regulatory Affairs

    Emeryville, CA

    $305,000 - $365,000

    2 months ago
    San Francisco Bay Area

    $300,000 - $350,000

    2 weeks ago
    Senior Director, Regulatory Affairs (Office or Remote)

    Hayward, CA

    $215,000 - $296,000

    5 days ago
    Senior Corporate Counsel / Director of Legal

    San Jose, CA

    $161,000 - $200,000

    1 month ago
    Menlo Park, CA

    $252,000 - $300,000

    1 month ago
    We're unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI.

    #J-18808-Ljbffr


  • Synergy Solutions Hercules, United States

    Essential Onsite · - no hybrid. M-F 8:00 to 4:30 however we are flexible. · *Less than 1 year experience in IVD medical device industry is acceptable* · - Provide regulatory support for IVD products with multiple product groups within clinical diagnostics. · - Work with regulator ...


  • Partnership HealthPlan of California Fairfield, United States

    Overview: · Under supervision and direction of the Regulatory Affairs Manager, this position assists in supporting the plan-wide HIPAA program and Fraud, Waste, and Abuse (FWA) program and acts as a liaison between the plan and our regulatory agencies. This position coordinates ...

  • Entegee

    Regulatory Affairs

    2 weeks ago


    Entegee Hercules, United States

    Job Description · Job DescriptionSummary: Seeking a Regulatory Affairs Specialist with 2-5 years of experience in the IVD industry, to provide regulatory support for product transitions from IVDD to IVDR, ensuring compliance and assisting in documentation and labeling updates. Th ...


  • Partnership HealthPlan of California Fairfield, United States

    Overview: · To support the objectives of the regulatory and compliance program and to ensure related activities are in alignment with regulatory requirements, contractual obligations, and ethical standards. · Responsibilities: Maintains awareness and demonstrates understanding ...


  • Partnership HealthPlan of California Fairfield, United States

    Overview · To support the objectives of the regulatory and compliance program and to ensure related activities are in alignment with regulatory requirements, contractual obligations, and ethical standards. · Responsibilities · Maintains awareness and demonstrates understanding ...


  • Alameda Health System Walnut Creek, United States

    Summary · SUMMARY: · Plans, coordinates, monitors compliance with federal, state and local regulations; manages accreditation activities necessary for maintaining required accreditation; manages requirements for certifications and licensure from various organizations, such as Jo ...


  • Alameda Health System Novato, United States

    Summary · SUMMARY: Plans, coordinates, monitors compliance with federal, state and local regulations; manages accreditation activities necessary for maintaining required accreditation; manages requirements for certifications and licensure from various organizations, such as Join ...


  • Quantum Ventures Alamo, United States

    Allergopharma GmbH & Co. KG, located in Reinbek, is part of the Dermapharm AG corporate group and is an internationally operating pharmaceutical company specializing in the development, production, and distribution of products for the diagnosis and treatment of allergic diseases. ...


  • Ultragenyx Pharmaceutical Novato, United States

    Brisbane, CA; Novato, CA; Somerville, MA; or Woburn, MA · Why Join Us? · Be a hero for our rare disease patients · At Ultragenyx, we fundamentally believe that taking real impactful action to care for the needs of patients and our people is always the right thing to do.To achieve ...


  • Polaris Pharmaceuticals Inc. Vacaville, United States

    Role Title: Senior Manager/Associate Director, Regulatory Affairs CMC · Department: Regulatory Affairs · FLSA Exempt · CORE VALUES · Respect ● Passion ● Teamwork ● Integrity ● Honesty ● Commitment ● Collaboration · ROLE SUMMARY · In this role you will provide CMC strategy input, ...


  • Polaris Group Vacaville, United States

    Role Title: Senior Manager/Associate Director, Regulatory Affairs CMC · Department: Regulatory Affairs · FLSA Exempt · CORE VALUES · Respect ? Passion ? Teamwork ? Integrity ? Honesty ? Commitment ? Collaboration · ROLE SUMMARY · In this role you will provide CMC strategy ...


  • BioMarin Novato, United States

    Who We Are · BioMarin's Technical Operations group is responsible for creating our drugs for use in clinical trials and for scaling production of those drugs for the commercial market. These engineers, technicians, scientists and support staff build and maintain BioMarin's cuttin ...


  • Partnership HealthPlan of California Fairfield, United States

    Overview: · To develop and implement long-term quantitative analysis strategies to meet NCQA and DHCS · standards for reporting. To perform, and assist in the performance of, duties that ensure the · accuracy, completeness and truthfulness of enterprise wide regulatory reporti ...


  • The Fountain Group Fairfield, United States

    Pay: $35-40/hr · Location: Sylmar, CA - first 2-3 weeks of training must be onsite and then may WFH the rest of the time with One Day In the Office. · Duration: 6 months; possible temp to perm for candidates willing to come onsite · Prefers candidates that are local to Sylmar ...


  • CSL Plasma Fairfield, United States

    Job Description Summary · Provides medical oversight to Medical Staff Associates, including the training of other physicians and Medical Staff Associates. Usually serves as the primary center physician registered as the Laboratory Director with the Food and Drug Administration (F ...


  • Napa Valley College Napa, United States

    **DESCRIPTION**: · **OPEN UNTIL FILLED with an initial review on the week of June 10, 2024.** · Napa Valley College is seeking an individual with demonstrated administrative skills to join an outstanding team of faculty, staff, and administrators to provide high quality programs ...


  • County of Contra Costa, California Martinez, United States

    **The Position**: · **The Board of Supervisors have authorized the following future salary increases**: · **5% on July 1, 2024** · **5% on July 1, 2025** · **Why Join Contra Costa County Health Services?** · The Contra Costa County Health Services Department is offering an excell ...

  • Calpine

    Dir Governmental

    1 week ago


    Calpine Walnut Creek, United States

    Calpine Corporation is America's largest generator of electricity from natural gas and geothermal resources with operations in competitive power markets. Its fleet of 76 power plants in operation and one under construction represents nearly 26,000 megawatts of generation capacity ...


  • UPSIDE Foods Berkeley, United States

    Job Description · Job DescriptionAbout us Based in Berkeley, CA, UPSIDE Foods grows meat, poultry, and seafood directly from real animal cells. These products are not vegan or vegetarian—they are delicious meat, made without the need to raise and slaughter billions of animals. In ...


  • Entegee Hercules, United States

    Job Description · Job DescriptionSummary: Seeking a Regulatory Affairs Specialist with 0-2 years of experience in IVD regulatory affairs to provide regulatory support for IVD products within clinical diagnostics. · Job Requirements: · 0-2 years of experience in IVD regulatory aff ...