Talent.com
Principal Specialist, Regulatory Affairs

Principal Specialist, Regulatory Affairs

ImmunityBioSummit, NJ, United States
job_description.job_card.30_days_ago
serp_jobs.job_preview.job_type
  • serp_jobs.job_card.full_time
job_description.job_card.job_description

Company Overview

ImmunityBio, Inc. (NASDAQ : IBRX) is a commercial-stage biotechnology company developing cell and immunotherapy products that are designed to help strengthen each patient's natural immune system, potentially enabling it to outsmart the disease and eliminate cancerous or infected cells. We envision a day when we no longer fear cancer, but can conquer it, thanks to the biological wonder that is the human immune system. Our scientists are working to develop novel therapies that harness that inherent power by amplifying both branches of the immune system, attacking cancerous or infected cells today while building immunological memory for tomorrow. The goal : to reprogram the patient's immune system and treat the host rather than just the disease.

Why ImmunityBio?

  • ImmunityBio is developing cutting-edge technology with the goal to transform the lives of patients with cancer and develop next-generation therapies and vaccines that complement, harness and amplify the immune system to defeat cancers and infectious diseases.
  • Opportunity to join a publicly traded biopharmaceutical company with headquarters in Southern California.
  • Work with a collaborative team with the ability to work across different areas of the company.
  • Ability to join a growing company with professional development opportunities.

Position Summary

The Principal, Specialist, Regulatory Affairs will provide expertise to the organization in the development of regulatory compliance strategies and in ensuring its conformance to Health Authority requirements.

Essential Functions

  • Serve as a Regulatory Affairs subject matter expert to the Regulatory Affairs team and organization.
  • Approve, review, or prepare common technical documents (CTD) for technical content and compliance with regulatory requirements
  • Responsible for maintaining compliance with US and International Health Authority regulations for products under development and for marketed products.
  • Assist with developing and evaluating regulatory strategy
  • Keep abreast of internal and external changes, trends, and developments to the regulatory environment that may have an impact on ImmunityBio products.
  • Author and review departmental SOPs, as well as other SOPs that may impact Regulatory Affairs.
  • Performs other special projects and duties as requested.
  • Education & Experience

  • Bachelor's Degree in life sciences required; Master's degree preferred
  • 10+ years of relevant regulatory compliance experience in pharmaceutical drug development required
  • Knowledge and experience with organizing responses to Regulatory Authority requests required
  • Experience with US and International Health Authority regulatory submissions preferred
  • Knowledge, Skills, & Abilities

  • Knowledge of FDA, ICH and other guidance documents and requirements
  • Knowledge of organizing responses to Regulatory Authority requests
  • Strong knowledge of Health Authority regulatory requirements / guidelines
  • Strong project management and computer skills (including Microsoft office)
  • Strong document management experience (hard and e-copy)
  • Ability to work with firm deadlines and adapt quickly to changing requirements and priorities
  • Strong organizational skills, written / oral communication skills and attention to detail
  • Ability to manage conflicting priorities and respond in a timely, effective manner
  • Working Environment / Physical Environment

  • This is a full-time position (40 hours per week) Monday through Friday.
  • This role may need to sit for long periods of time and use various computer programs.
  • This desk-based role involves the close study of scientific and regulatory documents.
  • They will work closely with scientific colleagues throughout the day, often on a project team basis.
  • Position Summary

    The Principal, Specialist, Regulatory Affairs will provide expertise to the organization in the development of regulatory compliance strategies and in ensuring its conformance to Health Authority requirements.

    Essential Functions

  • Serve as a Regulatory Affairs subject matter expert to the Regulatory Affairs team and organization.
  • Approve, review, or prepare common technical documents (CTD) for technical content and compliance with regulatory requirements
  • Responsible for maintaining compliance with US and International Health Authority regulations for products under development and for marketed products.
  • Assist with developing and evaluating regulatory strategy
  • Keep abreast of internal and external changes, trends, and developments to the regulatory environment that may have an impact on ImmunityBio products.
  • Author and review departmental SOPs, as well as other SOPs that may impact Regulatory Affairs.
  • Performs other special projects and duties as requested.
  • Education & Experience

  • Bachelor's Degree in life sciences required; Master's degree preferred
  • 10+ years of relevant regulatory compliance experience in pharmaceutical drug development required
  • Knowledge and experience with organizing responses to Regulatory Authority requests required
  • Experience with US and International Health Authority regulatory submissions preferred
  • Knowledge, Skills, & Abilities

  • Knowledge of FDA, ICH and other guidance documents and requirements
  • Knowledge of organizing responses to Regulatory Authority requests
  • Strong knowledge of Health Authority regulatory requirements / guidelines
  • Strong project management and computer skills (including Microsoft office)
  • Strong document management experience (hard and e-copy)
  • Ability to work with firm deadlines and adapt quickly to changing requirements and priorities
  • Strong organizational skills, written / oral communication skills and attention to detail
  • Ability to manage conflicting priorities and respond in a timely, effective manner
  • Working Environment / Physical Environment

  • This is a full-time position (40 hours per week) Monday through Friday.
  • This role may need to sit for long periods of time and use various computer programs.
  • This desk-based role involves the close study of scientific and regulatory documents.
  • They will work closely with scientific colleagues throughout the day, often on a project team basis.
  • This position is eligible for a discretionary bonus and equity award. The annual base pay range for this position is below. The specific rate will depend on the successful candidate's qualifications, prior experience as well as geographic location.

    $162,000 (entry-level qualifications) to $180,000 (highly experienced) annually

    The application window is anticipated to close on 60 days from when it is posted or sooner if the position is filled or closed.

    ImmunityBio employees are as valuable as the people we serve. We have built a resource of robust benefit offerings to best support the total wellbeing of our team members and their families. Our competitive total rewards benefits package, for eligible employees, include : Medical, Dental and Vision Plan Options

  • Health and Financial Wellness Programs
  • Employer Assistance Program (EAP)
  • Company Paid and Voluntary Life / AD&D, Short-Term and Long-Term Disability
  • Healthcare and Dependent Care Flexible Spending Accounts
  • 401(k) Retirement Plan with Company Match
  • 529 Education Savings Program
  • Voluntary Legal Services, Identity Theft Protection, Pet Insurance and Employee Discounts, Rewards and Perks
  • Paid Time Off (PTO) includes : 11 Holidays
  • Exempt Employees are eligible for Unlimited PTO
  • Non-Exempt Employees are eligible for 10 Vacation Days, 56 Hours of Health Pay, 2 Personal Days and 1 Cultural Day
  • We are committed to providing you with the tools and resources you need to optimize your Health and Wellness.
  • At ImmunityBio, we are an equal opportunity employer dedicated to diversity in the workplace. Our policy is to provide equal employment opportunities to all qualified persons without regard to race, gender, color, disability, national origin, age, religion, union affiliation, sexual orientation, veteran status, citizenship, gender identity and / or expression, or other status protected by law.

    serp_jobs.job_alerts.create_a_job

    Regulatory Specialist • Summit, NJ, United States

    Job_description.internal_linking.related_jobs
    • serp_jobs.job_card.promoted
    Senior Regulatory Specialist

    Senior Regulatory Specialist

    Givaudan FragrancesEast Hanover, NJ, United States
    serp_jobs.job_card.full_time
    Join us and celebrate the beauty of human experience.Create for happier, healthier lives, with love for nature.Together, with our customers, we deliver food innovations, craft inspired fragrances a...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_30
    • serp_jobs.job_card.promoted
    Senior Manager, Regulatory Affairs

    Senior Manager, Regulatory Affairs

    Eikon TherapeuticsJersey City, NJ, US
    serp_jobs.job_card.full_time
    Senior Manager, Regulatory Affairs.Eikon Therapeutics is a new biopharmaceutical company employing revolutionary technology at the intersection of chemistry, engineering, computation, and biology t...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_variable_days
    • serp_jobs.job_card.promoted
    Senior Manager, Regulatory Affairs Advertising & Promotion

    Senior Manager, Regulatory Affairs Advertising & Promotion

    RegeneronTarrytown, NY, US
    serp_jobs.job_card.full_time
    Senior Manager, Regulatory Affairs, Advertising and Promotion.The Senior Manager position within the Regulatory Affairs department requires the ability to apply clinical development knowledge in co...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_30
    • serp_jobs.job_card.promoted
    Senior Regulatory Affairs Specialist

    Senior Regulatory Affairs Specialist

    Atrium StaffingNew York, NY, US
    serp_jobs.job_card.full_time
    Our client is a well-established global brand with a focus on delivering quality personal care products to the consumer.Some brands are B2B, while others are B2C. This company has received awards fo...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_variable_days
    • serp_jobs.job_card.promoted
    Senior Analyst, Regulatory

    Senior Analyst, Regulatory

    Oscar HealthNew York, NY, US
    serp_jobs.job_card.full_time
    Oscar is the first health insurance company built around a full stack technology platform and a relentless focus on serving our members. We started Oscar in 2012 to create the kind of health insuran...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_variable_days
    • serp_jobs.job_card.promoted
    Director, Regulatory Affairs

    Director, Regulatory Affairs

    LVMH Perfumes & CosmeticsEast Brunswick, NJ, US
    serp_jobs.job_card.full_time
    LVMH's Beauty activities benefit from exceptional dynamism that relies on both the longevity and development of key lines, and on the boldness of new creations. All are driven by the same values : a ...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_30
    • serp_jobs.job_card.promoted
    Head of Regulatory Reporting

    Head of Regulatory Reporting

    SchonfeldNew York, NY, US
    serp_jobs.job_card.full_time
    We are seeking an experienced regulatory-reporting leader to own the global filings program across our multi-strategy hedge fund. You will partner with Compliance, Finance, Risk, Treasury, Operation...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_30
    • serp_jobs.job_card.promoted
    Associate Director, Regulatory Affairs – BLA

    Associate Director, Regulatory Affairs – BLA

    Kaztronix LLCPiscataway, NJ, United States
    serp_jobs.job_card.full_time
    Associate Director, Regulatory Affairs – Biosimilar / BLA.Regulatory expert in the area of Biosimilar / BLA submissions including strategize, compile, review and manage / lead regulatory submissions.Subj...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_variable_days
    • serp_jobs.job_card.promoted
    Global Program Regulatory Manager (Remote)

    Global Program Regulatory Manager (Remote)

    Novartis Group CompaniesEast Hanover, NJ, United States
    serp_jobs.filters.remote
    serp_jobs.job_card.full_time
    The Global Program Regulatory Manager (GPRM) works with some independence under limited supervision to provide strategic and operational regulatory direction and may support the RA global program t...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_variable_days
    • serp_jobs.job_card.promoted
    Executive Director Global Regulatory Affairs

    Executive Director Global Regulatory Affairs

    EPM ScientificNutley, NJ, United States
    serp_jobs.job_card.full_time
    A leading global biopharmaceutical organization is seeking a seasoned.Executive Director of Global Regulatory Strategy.This is a high-impact, hands-on leadership role ideal for a strategic thinker ...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_variable_days
    • serp_jobs.job_card.promoted
    Director of Regulatory Affairs

    Director of Regulatory Affairs

    Scientific SearchMorristown, NJ, US
    serp_jobs.job_card.full_time
    Morristown, NJ area (2 days per week onsite).Base salary up to $220k, Plus Bonus, Plus LTI.Scientific Search has recently partnered with an innovative biopharmaceutical company who has tasked us in...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_30
    • serp_jobs.job_card.promoted
    Director Regulatory Affairs

    Director Regulatory Affairs

    Sandoz Inc.Princeton, NJ, United States
    serp_jobs.job_card.full_time
    Sandoz continues to go through an exciting and transformative period as a global leader and pioneering provider of sustainable Biosimilar and Generic medicines. As we continue down this new and ambi...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_30
    • serp_jobs.job_card.promoted
    Executive Director, Global Regulatory Affairs - Neurology

    Executive Director, Global Regulatory Affairs - Neurology

    EisaiNutley, NJ, United States
    serp_jobs.job_card.full_time
    At Eisai, satisfying unmet medical needs and increasing the benefits healthcare provides to patients, their families, and caregivers is Eisai's human health care (hhc) mission.We're a growing pharm...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_30
    • serp_jobs.job_card.promoted
    Director, Regulatory Affairs Advertising & Promotion

    Director, Regulatory Affairs Advertising & Promotion

    Novartis Group CompaniesEast Hanover, NJ, United States
    serp_jobs.job_card.full_time
    Novartis has an incredible opportunity for a talented individual to join our team as the Director, Regulatory Affairs Advertising & Promotion. You will provide strategic regulatory advice on.US orga...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_30
    • serp_jobs.job_card.promoted
    Manager, Compliance

    Manager, Compliance

    Novartis Group CompaniesEast Hanover, NJ, United States
    serp_jobs.job_card.full_time
    Join Novartis's dynamic Managed Markets Finance (MMF) Compliance team as a Manager, where you'll play a key role in embedding financial and IT controls across MMF operations.You'll help drive compl...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_variable_days
    • serp_jobs.job_card.promoted
    • serp_jobs.job_card.new
    Sr. Specialist, Regulatory Affairs

    Sr. Specialist, Regulatory Affairs

    International Flavors and FragrancesNew York, NY, United States
    serp_jobs.job_card.full_time
    Are you passionate about innovation that transforms everyday products into extraordinary experiences?.IFF is a global leader in flavors, fragrances, food ingredients and health & biosciences.We del...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_variable_hours
    • serp_jobs.job_card.promoted
    Executive Director, Integrated Trial Process, PRS

    Executive Director, Integrated Trial Process, PRS

    Novartis Group CompaniesEast Hanover, NJ, United States
    serp_jobs.job_card.full_time
    We work collaboratively to integrate cross-functional expertise into streamlined, end-to-end trial processes underpinned by innovation and risk-based quality management, so Novartis can deliver hig...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_variable_days
    • serp_jobs.job_card.promoted
    • serp_jobs.job_card.new
    Senior Director, Global Regulatory Affairs

    Senior Director, Global Regulatory Affairs

    Interparfums, Inc.New York, NY, US
    serp_jobs.job_card.full_time
    Part of the Interparfums group founded in 1982, Interparfums USA develops, manufactures and distributes prestige fragrances as the exclusive worldwide licensee for Abercrombie & Fitch, Anna Sui...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_variable_hours