Talent.com
serp_jobs.error_messages.no_longer_accepting
Principal Specialist, Regulatory Affairs (Summit)

Principal Specialist, Regulatory Affairs (Summit)

ImmunityBioSummit, NJ, US
job_description.job_card.variable_hours_ago
serp_jobs.job_preview.job_type
  • serp_jobs.job_card.full_time
  • serp_jobs.job_card.part_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, US

    Job_description.internal_linking.related_jobs
    • serp_jobs.job_card.promoted
    Product & Regulatory Operations Specialist

    Product & Regulatory Operations Specialist

    Linda Werner & AssociatesNew York, NY, US
    serp_jobs.job_card.full_time
    The Product & Regulatory Operations organization plays a critical role in safeguarding users and businesses across our platforms. It delivers operational excellence for emerging and high-priorit...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_variable_days
    • serp_jobs.job_card.promoted
    Associate Director Regulatory Affairs – Biosimilar / BLA

    Associate Director Regulatory Affairs – Biosimilar / BLA

    Amneal Pharmaceuticals LLCPiscataway Township, NJ, United States
    serp_jobs.job_card.full_time
    Regulatory expert in the area of Biosimilar / BLA submissions including strategize, compile, review and manage / lead regulatory submissions. Subject matter expert in the area of Biologics.Promotes and ...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_30
    • serp_jobs.job_card.promoted
    Associate Director, Regulatory Affairs

    Associate Director, Regulatory Affairs

    Eikon TherapeuticsJersey City, NJ, US
    serp_jobs.job_card.full_time
    Associate Director, Regulatory Affairs.Eikon Therapeutics is a new biopharmaceutical company employing revolutionary technology at the intersection of chemistry, engineering, computation, and biolo...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_30
    • serp_jobs.job_card.promoted
    Regulatory Affairs Manager

    Regulatory Affairs Manager

    Katalyst Healthcares & Life SciencesNewark, NJ, US
    serp_jobs.job_card.full_time
    Responsibilities : The Regulatory Affairs Manager is responsible for the development and execution of global regulatory strategy and tactical planning for assigned microbiology on market products or...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_30
    • serp_jobs.job_card.promoted
    Associate Director / Director, Regulatory Affairs -GDP Contractor

    Associate Director / Director, Regulatory Affairs -GDP Contractor

    Shionogi Inc.Florham Park, NJ, United States
    serp_jobs.job_card.full_time
    Support the Regulatory Affairs (Executive Director) in developing and executing regulatory strategies for antiviral programs globally or within specific regions. Assisting in preparing presentations...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_30
    • serp_jobs.job_card.promoted
    Regulatory Affairs Associate

    Regulatory Affairs Associate

    ActalentPrinceton, NJ, US
    serp_jobs.job_card.full_time
    Job Title : Regulatory Affairs Specialist.Ensures a controlled documentation system, record retention, and information services including electronic records retention processes in accordance with re...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_variable_days
    • serp_jobs.job_card.promoted
    Regulatory Stewardship Specialist

    Regulatory Stewardship Specialist

    Sika USALyndhurst, NJ, US
    serp_jobs.job_card.full_time
    Regulatory Stewardship Specialist.With more than 100 years of experience, Sika is a worldwide innovation and sustainability leader in the development and production of systems and products for comm...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_variable_days
    • serp_jobs.job_card.promoted
    Manager, Global Scientific & Regulatory Affairs

    Manager, Global Scientific & Regulatory Affairs

    IngredionBound Brook, NJ, US
    serp_jobs.job_card.full_time
    Ingredion is seeking a knowledgeable and motivated Regulatory Affairs Manager to support innovation initiatives, assist in securing ingredient approvals, and help ensure regulatory compliance acros...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_variable_days
    • serp_jobs.job_card.promoted
    Regulatory Relations

    Regulatory Relations

    Mizuho BankNew York, NY, US
    serp_jobs.job_card.full_time
    Assistant Vice President, Regulatory Relations.Operations ("MUSO") Regulatory Affairs Group is responsible for managing the Bank's regulatory relationships and supervisory engagement across MUSO, e...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_30
    • serp_jobs.job_card.promoted
    RegulatoryAffairsSeniorManager

    RegulatoryAffairsSeniorManager

    Katalyst Healthcares & Life SciencesTarrytown, NY, US
    serp_jobs.job_card.full_time
    Responsibilities : US Agent for all products, responsible for communication between the FDA and manufacturing sites.Communicate and follow-up status with FDA for any Chemistry, Bioequivalence and Pa...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_30
    • serp_jobs.job_card.promoted
    Regulatory Affairs Specialist II

    Regulatory Affairs Specialist II

    Katalyst Healthcares & Life SciencesSecaucus, NJ, US
    serp_jobs.job_card.full_time
    Regulatory Submission Specialist.This position is responsible for the preparation of regulatory submissions required to market medical devices in both the U. Europe, support of international product...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_30
    • serp_jobs.job_card.promoted
    Senior Manager, Regulatory Affairs Strategy - Oncology

    Senior Manager, Regulatory Affairs Strategy - Oncology

    RegeneronTarrytown, NY, US
    serp_jobs.job_card.full_time
    Senior Manager, Regulatory Affairs.The Senior Manager, Regulatory Affairs will report to the Global Regulatory Liaison (GRL) and provides support to the GRL in all aspects of regulatory affairs rel...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_variable_days
    • serp_jobs.job_card.promoted
    Principal Regulatory Affairs Specialist - Ad Promo

    Principal Regulatory Affairs Specialist - Ad Promo

    Bausch + LombBound Brook, NJ, US
    serp_jobs.job_card.full_time
    Principal Regulatory Affairs Specialist - Ad Promo.Bausch + Lomb is a leading global eye health company dedicated to protecting and enhancing the gift of sight for millions of people around the wor...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_30
    • serp_jobs.job_card.promoted
    Regulatory Affairs Specialist III

    Regulatory Affairs Specialist III

    HireTalentBound Brook, NJ, US
    serp_jobs.job_card.full_time
    Regulatory Affairs Specialist III.Location : Bridgewater, NJ Duration : 9 Months.Manager will consider candidates to be based in either Bridgewater, New Jersey or Cambridge, Massachusetts.Please spec...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_30
    • serp_jobs.job_card.promoted
    Regulatory Affairs Specialist

    Regulatory Affairs Specialist

    Cynet SystemsPiscataway, NJ, US
    serp_jobs.job_card.full_time
    Responsibilities : Utilizing multiple software systems (SAP, Veeva, Excel) to find and record packaging data to place all findings into one document for reference. Calling out differences from existi...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_30
    • serp_jobs.job_card.promoted
    Executive Director / VP Quality and Regulatory

    Executive Director / VP Quality and Regulatory

    GTS ScientificPrinceton, NJ, US
    serp_jobs.job_card.full_time
    Executive Director / VP Quality and Regulatory.On-site (with flexibility for hybrid work).A growing, global contract services provider in the pharmaceutical industry is seeking an accomplished Execut...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_variable_days
    • serp_jobs.job_card.promoted
    Program Director of Regulatory Reporting

    Program Director of Regulatory Reporting

    RIT SolutionsWayne, NJ, US
    serp_jobs.job_card.full_time
    Program Director Of Regulatory Reporting.The Program Director will be leading large regulatory reporting projects in for banking organizations in the USA and has preferably led projects related to ...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_30
    • serp_jobs.job_card.promoted
    Associate Director, Global Regulatory Affairs

    Associate Director, Global Regulatory Affairs

    OrganonJersey City, NJ, US
    serp_jobs.job_card.full_time
    The Associate Director, Global Regulatory Lead (GRL), will be responsible for the development and implementation of worldwide regulatory strategies for projects in their assigned therapeutic area p...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_30
    • serp_jobs.job_card.promoted
    Global Regulatory Affairs Compliance and Planning, Sr. Manager

    Global Regulatory Affairs Compliance and Planning, Sr. Manager

    Kyowa KirinPrinceton, NJ, US
    serp_jobs.job_card.full_time
    Kyowa Kirin is a global specialty pharmaceutical company that applies state-of-the-art biotechnologies to discover and deliver novel medicines in four areas of unmet need : oncology, nephrology, imm...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_30
    • serp_jobs.job_card.promoted
    Staff Regulatory Affairs Specialist

    Staff Regulatory Affairs Specialist

    Becton DickinsonFranklin Lakes, NJ, US
    serp_jobs.job_card.full_time
    The Staff RA Specialist will represent Regulatory Affairs within the Worldwide Infusion Preparation and Delivery (WWIPD) platform on compliance projects, product engineering, new product developmen...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_30