Jobs
>
Emeryville

    Senior Manager, Regulatory Affairs - Emeryville, United States - Kyverna Therapeutics, Inc.

    Kyverna Therapeutics, Inc.
    Kyverna Therapeutics, Inc. Emeryville, United States

    2 weeks ago

    Default job background
    Description
    Kyverna Therapeutics is a patient-centered, clinical-stage biopharmaceutical company focused on developing cell therapies for patients suffering from autoimmune diseases.

    The Kyverna therapeutic platform leverages advanced T cell engineering to suppress and eliminate autoreactive immune cells at the origin of autoimmune and inflammatory diseases.

    Be at the forefront of cell therapy innovation by joining scientists, industry veterans and healthcare visionaries and help transform how autoimmune diseases are treated
    Kyverna is seeking an experienced and driven Manager/Senior Manager of Regulatory Affairs to join our regulatory team. This role is pivotal in shaping and executing regulatory strategies for our innovative therapies.

    We are looking for candidates with a proven track record in Clinical/Nonclinical Regulatory Affairs within the biotechnology or pharmaceutical sector.


    Responsibilities:

    Regulatory Strategy:
    Contribute to the development and execution of regulatory strategies aligned with corporate objectives and timelines.
    Assist in planning and coordinating regulatory submissions and interactions with health authorities.

    Regulatory Submissions:


    Prepare, review, compile, and archive regulatory submissions and correspondence, including Investigational New Drug (IND) applications, Biological License Applications (BLA), Regenerative Medicine for Advanced Therapy (RMAT) Applications, Marketing Authorization Applications (MAAs), Clinical Trial Applications (CTAs), Orphan Drug Designation (ODD) Applications, Pediatric Investigational Plans (PIP), Suspected Unexpected Serious Adverse Reaction (SUSAR) submissions, Development Safety Update Report (DSUR) submissions, and other submissions as necessary.

    Ensure regulatory documents are compliant with global regulatory requirements and guidelines.

    Regulatory Expertise :
    Leverage regulatory knowledge to provide guidance and insights to support regulatory strategies.
    Stay informed about evolving regulatory requirements, industry trends, and best practices.

    Quality and Compliance:
    Collaborate with Quality Assurance and Regulatory teams to ensure adherence to Good Manufacturing Practices (GMP) and regulatory compliance.
    Support regulatory inspections and audits as needed.

    Cross-Functional Collaboration :


    Collaborate with cross-functional teams, including Clinical, Clinical Operations, Quality Assurance, Manufacturing, Nonclinical, Technical Development, and other relevant departments, to align regulatory strategies with organizational goals.

    Stay updated on evolving regulatory requirements and guidelines relevant to our therapies.
    Assess changes in the regulatory environment and effectively communicate their impact on our product development strategy.

    Requirements:
    Bachelor's or advanced degree in a relevant scientific field.
    Minimum of 2-5 years of industry experience in Regulatory Affairs within the biotechnology or pharmaceutical sector.
    Highly experienced in EU clinical trial applications
    Proficiency in global regulatory requirements and guidelines.
    Experience in preparing regulatory submissions, including INDs, and MAAs.
    High attention to detail, very strong organizational skills, and project management capabilities.
    Effective communication and interpersonal skills, with the ability to collaborate effectively in cross-functional teams.
    Ability to adapt to a dynamic regulatory environment.
    $165,000 - $195,000 a year

    The salary range for this position is from $165,000 - $195,000 USD annually.

    This salary range is an estimate of what we reasonably expect to pay for this posted position, and the actual salary may vary based on various factors, including without limitation individual education, experience, tenure, skills and abilities, as well as internal equity and alignment with market data.

    This position is also eligible for bonus, benefits, and participation in Company's stock option plan.
    Kyverna is an Equal Opportunity Employer and prohibits discrimination and harassment of any kind.

    Kyverna is committed to the principle of equal employment opportunity for all employees and does not discriminate on the basis of race, religion, color, sex, gender identify, sexual orientation, age, non-disqualifying physical or mental disability, national origin, veteran status or any other legally protected status.

    EOE/AA/Vets

    #J-18808-Ljbffr
  • Synergy Solutions

    Regulatory Affairs Specialist

    2 weeks ago

    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 ...

  • Alameda Health System

    Regulatory Affairs Manager

    5 days ago

    Alameda Health System Emeryville, 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 ...

  • Mastech Digital

    Regulatory Affairs Manager

    4 days ago

    Mastech Digital Oakland, United States

    Position: HIM Director-Regulatory Affairs Manager · Location: Oakland CA USA days onsite) · Duration: 12+ Months (Possibility to extend/Convert) · Required Qualifications: · ● Bachelor's degree with additional 10 years of progressively responsible experience managing quality comp ...

  • Alameda Health System

    Regulatory Affairs Manager

    6 days ago

    Alameda Health System Oakland, 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 ...

  • AbbVie

    Regulatory Affairs Manager

    12 hours ago

    AbbVie South San Francisco, United States

    **Company Description** · **Job Description** Key Responsibilities** · - Responsible for providing regulatory strategy & support for global development. · - Responsible for supporting teams & efforts around major filing activities & Regulatory Health Authority (RHA) interactions ...

  • Mastech Digital

    Regulatory Affairs Manager

    1 hour ago

    Mastech Digital Oakland, United States

    Position: · HIM Director-Regulatory Affairs Manager · Location: · Oakland CA USA days onsite) · Duration: · 12+ Months (Possibility to extend/Convert) · Required Qualifications: · ● Bachelor's degree with additional 10 years of progressively responsible experience managing qu ...

  • Cytokinetics

    Associate Director, Regulatory Affairs

    2 weeks ago

    Cytokinetics South San Francisco, United States

    Reporting to the Senior Director, Regulatory Affairs, the Associate Director of Regulatory Affairs leads regulatory support for assigned programs to ensure sound regulatory planning and tactical implementation of US and international development strategies. · **Responsibilities** ...

  • Collabera

    Regulatory Affairs Associate

    1 day ago

    Collabera Alameda, United States

    Home · Search Jobs · Job Description · Regulatory Affairs Associate · Contract: Alameda, California, US · Salary: $55.00 Per Hour · Job Code: · End Date: · Days Left: 12 days, 3 hours left · Apply · To discuss more about this job opportunity, please reach out to Chitrank ...

  • Collabera

    Regulatory Affairs Associate

    1 hour ago

    Collabera Alameda, United States

    Home · Search Jobs · Job Description · Regulatory Affairs Associate · Contract: Alameda, California, US · Salary: $55.00 Per Hour · Job Code: · End Date: · Days Left: 26 days, 3 hours left · Apply · To discuss more about this job opportunity, please reach out to Chitrank ...

  • Collabera

    Regulatory Affairs Associate

    22 hours ago

    Collabera Alameda, United States

    Home · Search Jobs · Job Description · Regulatory Affairs Associate · Contract: Alameda, California, US · Salary: $55.00 Per Hour · Job Code: · End Date: · Days Left: 11 days, 3 hours left · Apply · To discuss more about this job opportunity, please reach out to Chitrank ...

  • Ascendis Pharma

    Head of Regulatory Affairs, Oncology

    2 weeks ago

    Ascendis Pharma Palo Alto, United States

    HybridPalo Alto, California, United StatesOncology, Regulatory, OncologyFull time1404 · Description · We are a dynamic, fast-growing biopharma company with offices in Denmark, Germany, and the United States. Today, we're advancing programs in Endocrinology Rare Disease, and Oncol ...

  • Abbott Laboratories company

    Regulatory Affairs Specialist

    1 hour ago

    Abbott Laboratories company Alameda, United States

    Regulatory Affairs Specialist – APAC - Diabetes Care (on-site) page is loaded · Regulatory Affairs Specialist – APAC - Diabetes Care (on-site) · Apply · locations · United States - California - Alameda · time type · Full time · posted on · Posted 3 Days Ago · job requisi ...

  • Infosoft

    Regulatory Affairs Specialist-4694

    1 week ago

    Infosoft Palo Alto, United States

    One of our clients is looking for a talented and highly motivated **Sr. Regulatory Affairs Specialist**. Please **send your resume** if you would like to pursue this opportunity and you authorize Infosoft to represent you for this position. · Here are the job position details for ...

  • Abbott

    Regulatory Affairs Specialist

    1 hour ago

    Abbott Alameda, United States

    Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medic ...

  • INTELLECTT INC

    Regulatory Affairs Specialist

    2 weeks ago

    INTELLECTT INC Alameda, United States

    Role: Regulatory Affairs AssociateLocation: Alameda, CADuration: 10 + MonthsShift Timings: 8 am to 5 pmJob Description: Experience in a medical device or similarly regulated industry Ability to schedule and organize multiple projects BS Engineering or Scientific Manager regulator ...

  • Exelixis

    Regulatory Affairs Associate

    2 weeks ago

    Exelixis Alameda, United States

    SUMMARY/JOB PURPOSE: · Responsible for managing and maintaining existing investigational new drug (IND) and clinical trial application (CTA) submissions and preparing amendments in compliance with guidelines and regulations. Coordinates, compiles, and tracks product applications ...

  • GForce Life Sciences

    Regulatory Affairs Associate

    3 weeks ago

    GForce Life Sciences Alameda, United States

    Regulatory Affairs Associate - On-site in Alameda, CA · Term & Start · 1-year contract with possibility to extend, starting ASAP · On-site in Alameda, CA · Pay Rate: Up to $40-48/hr based on experience ($80-96k) · FT hours, M-F 8a-5p · Business Unit: Diabetes Care · Interview Pr ...

  • INTELLECTT INC

    Regulatory Affairs Associate

    2 weeks ago

    INTELLECTT INC Alameda, United States

    Hello, · I Hope you are doing great. · This is Bhanu from Intellectt INC; weve got an important role Regulatory Affairs Associate -Alameda, CA with one of our prestigious clients. Interested candidates can please send your updated resume at · Role: Regulatory Affairs Associa ...

  • INTELLECTT INC

    Regulatory Affairs Specialist

    3 weeks ago

    INTELLECTT INC Alameda, United States

    Role: · Regulatory Affairs Associate · Location: · Alameda, CA · Duration: 10 + Months · Shift Timings: · 8 am to 5 pm · Job Description: · Experience in a medical device or similarly regulated industry · Ability to schedule and organize multiple projects · BS Engineering or ...

  • INTELLECTT INC

    Regulatory Affairs Associate

    2 weeks ago

    INTELLECTT INC Alameda, United States

    Hello, · I Hope you are doing great. · This is · Bhanu · from Intellectt INC; we've got an important role · Regulatory Affairs Associate - · Alameda, CA · with one of our prestigious clients. Interested candidates can please send your updated resume at · Role: Regulatory ...