Talent.com
No se aceptan más aplicaciones
Hengrui USA is hiring : Regulatory Publishing Specialist — 恒瑞-全球精英计划 in Princeton

Hengrui USA is hiring : Regulatory Publishing Specialist — 恒瑞-全球精英计划 in Princeton

MediabistroPrinceton, NJ, United States
Hace más de 30 días
Tipo de contrato
  • A tiempo completo
Descripción del trabajo

HR Management Trainee | Talent Acquisition at Hengrui Pharmaceuticals

Job Responsibilities

  • Assist Regulatory Affairs personnel in the preparation and submission of INDs / BLAs / NDAs and life cycle management.
  • Electronically format and publish electronic documents; builds Regulatory submission deliverables. Ensures quality, accuracy, and submission-readiness per Regulatory agency guidance and specifications, and internal procedures.
  • Provides guidance on good documentation and submission practices to project teams.
  • Provides input on submission timelines and eCTD content plans.
  • Reviews documents to ensure compliance with electronic requirements.
  • Support archiving (categorizing and classifying information) of Regulatory records pertaining to multiple Regulatory Applications (e.g., IND, BLA, MAA, Annual Reports, AEs), maintaining Regulatory Application indexes, tracking of regulatory submission documents, and special projects as needed.
  • Identifies and communicates regulatory system enhancement needs or technical issues.
  • Assist with maintaining Document Authoring Template Library and Template development.
  • Contribute to miscellaneous regulatory operational activities and special projects as assigned.

Qualifications

  • BA / BS degree in Life Sciences or related field
  • 1 – 3 years of experience in Regulatory Operations, Regulatory Affairs, or related publishing / technical documentation role
  • Basic knowledge of regulatory practices, electronic submission guidelines and requirements.
  • Familiarity with electronic Common Technical Document submission requirements during development, registration and commercialization
  • Experience working in a cross-functional environment and supporting submission deliverables.
  • Strong attention to detail, good organization, and collaboration skills.
  • Ability to manage multiple tasks simultaneously and meet deadlines.
  • Familiarity with applicable FDA, EMA and ICH guidelines related to regulatory submissions, clinical trials and marketing applications.
  • Familiarity with eCTD publishing systems, EDMS technology (Veeva Vault preferred), and document authoring tools and templates.
  • Proficiency in Microsoft Office Suite, Adobe, Excel.
  • Understanding of regulatory submission content and format requirements.
  • Understanding of applicable FDA and ICH guidelines related to regulatory submissions.
  • Clear understanding of regulatory submission content and format requirements.
  • Experienced in lifecycle management eCTD submissions including but not limited to, IND Safety, IND Investigator submissions and post marketing LCM.
  • Ability to work both independently and collaboratively in a fast-paced environment.
  • Detail-oriented with strong organizational and time-management skills.
  • Strong written and verbal communication skills.
  • Mandarin language skills a plus; East Coast (U.S.) location strongly preferred for time zone alignment.

    • Seniority level

  • Entry level

    • Employment type

  • Full-time

    • Job function

  • Writing / Editing

    • Industries

  • Pharmaceutical Manufacturing

    • #J-18808-Ljbffr

    Crear una alerta de empleo para esta búsqueda

    Is Hiring Publishing • Princeton, NJ, United States

    Ofertas relacionadas
    • Nueva oferta
    Senior Regulatory Affairs Specialist

    Senior Regulatory Affairs Specialist

    Tap Growth aiPhiladelphia, Pennsylvania, US
    A tiempo completo
    We're Hiring : Senior Regulatory Specialist! 🌟.We are seeking an experienced Senior Regulatory Specialist to ensure compliance with regulatory requirements and guide strategic regulatory decisions....Mostrar másÚltima actualización: hace 6 horas
    • Oferta promocionada
    Director, RA Global Regulatory Strategy

    Director, RA Global Regulatory Strategy

    AbbVieFlorham Park, NJ, US
    A tiempo completo
    Director, Regulatory Affairs Global Regulatory Strategy.AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical...Mostrar másÚltima actualización: hace 22 días
    • Oferta promocionada
    Regulatory Affairs Manager

    Regulatory Affairs Manager

    Katalyst Healthcares & Life SciencesNewark, NJ, US
    A tiempo completo
    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...Mostrar másÚltima actualización: hace más de 30 días
    • Oferta promocionada
    Regulatory Affairs Associate

    Regulatory Affairs Associate

    Katalyst Healthcares & Life SciencesWhippany, NJ, US
    A tiempo completo
    Responsibilities : Manage assigned projects to ensure thoroughness, accuracy, and timeliness of CMC dossiers and responses. Responsible for filing necessary applications and handling all government i...Mostrar másÚltima actualización: hace más de 30 días
    • Oferta promocionada
    Regulatory Publishing Manager I

    Regulatory Publishing Manager I

    AequorPiscataway, NJ, US
    A tiempo completo
    Two new Regulatory Manager requisitions are about to go live in the system; one based in Princeton, NJ, and the other in San Diego, CA. Job Title : Regulatory Publishing Manager I Duties The Manager / ...Mostrar másÚltima actualización: hace más de 30 días
    • Oferta promocionada
    Regulatory Affairs Specialist (Hybrid)

    Regulatory Affairs Specialist (Hybrid)

    Spectrum VascularBridgewater, NJ, US
    A tiempo completo
    Spectrum Vascular is an innovative medical device company focused on vascular access and medication management.Our mission is to improve the lives of patients worldwide by providing caregivers with...Mostrar másÚltima actualización: hace 4 días
    • Oferta promocionada
    Manager, Global Scientific & Regulatory Affairs

    Manager, Global Scientific & Regulatory Affairs

    IngredionBound Brook, NJ, US
    A tiempo completo
    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...Mostrar másÚltima actualización: hace más de 30 días
    Senior Regulatory and Compliance Specialist

    Senior Regulatory and Compliance Specialist

    ArdenaSomerset, New Jersey, US
    A tiempo completo
    Quick Apply
    As a leading Contract Development and Manufacturing Organization (CDMO), Ardena partners with pharmaceutical companies of all sizes—from emerging biotech to global industry leaders—united by the mi...Mostrar másÚltima actualización: hace 24 días
    Sanofi is hiring : Global Regulatory Affairs-Advertising and Promotion Excellence

    Sanofi is hiring : Global Regulatory Affairs-Advertising and Promotion Excellence

    MediabistroConvent Station, NJ, United States
    A tiempo completo
    Global Regulatory Affairs-Advertising and Promotion Excellence Head page is loaded Global Regulatory Affairs-Advertising and Promotion Excellence Head Job Title : GRA-Advertising and Promotion Ex...Mostrar másÚltima actualización: hace más de 30 días
    • Oferta promocionada
    Regulatory Affairs Specialist

    Regulatory Affairs Specialist

    Cynet SystemsPiscataway, NJ, US
    A tiempo completo
    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...Mostrar másÚltima actualización: hace más de 30 días
    • Oferta promocionada
    Regulatory Affairs Specialist II

    Regulatory Affairs Specialist II

    Katalyst Healthcares & Life SciencesNewark, NJ, US
    A tiempo completo
    Responsibilities : This position is responsible for the preparation of regulatory submissions required to market medical devices in both the U. Europe, support of international product registrations ...Mostrar másÚltima actualización: hace más de 30 días
    • Oferta promocionada
    Principal Regulatory Affairs Specialist - Ad Promo

    Principal Regulatory Affairs Specialist - Ad Promo

    Bausch + LombBound Brook, NJ, US
    A tiempo completo
    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...Mostrar másÚltima actualización: hace más de 30 días
    • Oferta promocionada
    Regulatory Affairs Specialist III

    Regulatory Affairs Specialist III

    HireTalentBound Brook, NJ, US
    A tiempo completo
    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...Mostrar másÚltima actualización: hace más de 30 días
    • Oferta promocionada
    Regulatory and Medical affairs - Sr. Manager, US Medical

    Regulatory and Medical affairs - Sr. Manager, US Medical

    Tech DigitalMadison, NJ, US
    A tiempo completo
    Senior Manager, Us Medical Myeloid, Aml & Mf 100% On-site.At client, we are inspired by a single vision transforming patients' lives through science. In oncology, hematology, immunology and cardiov...Mostrar másÚltima actualización: hace más de 30 días
    • Oferta promocionada
    Global Regulatory Lead

    Global Regulatory Lead

    StaffingMadison, NJ, US
    A tiempo completo
    Estimate Start Date July 7th At LEO Pharma, our mission transcends the conventional.We're on an ambitious path to become the leaders in medical dermatology worldwide. If you're ready to make a diffe...Mostrar másÚltima actualización: hace más de 30 días
    • Oferta promocionada
    • Nueva oferta
    Bristol Myers Squibb Global Regulatory Strategy Fellowship

    Bristol Myers Squibb Global Regulatory Strategy Fellowship

    Rutgers, the State University of New JerseyLawrenceville, NJ, US
    A tiempo completo
    Fellowship Position Office Location : (Hybrid) 3401 Princeton Pike, Lawrenceville, NJ 08648.POST-DOCTORAL PHARMACEUTICAL INDUSTRY FELLOWSHIP – Rutgers, The State University of New Jersey, Ernest Mar...Mostrar másÚltima actualización: hace menos de 1 hora
    • Oferta promocionada
    Regulatory Assurance Specialist

    Regulatory Assurance Specialist

    ArxadaMorristown, NJ, US
    A tiempo completo
    A member of a world-class regulatory team focused on regulatory excellence to support and manage supplemental registrations for Arxada and affiliated organizations. This team member will be ensuring...Mostrar másÚltima actualización: hace 13 días
    • Oferta promocionada
    Regulatory and Medical affairs - Medical Promotional Review Advisor

    Regulatory and Medical affairs - Medical Promotional Review Advisor

    Tech DigitalMadison, NJ, US
    A tiempo completo
    Top 3-5 skills you are looking for : Advanced degree experience in medical and / or regulatory affairs clinical background strong organizational and communication skills. This position reports to the M...Mostrar másÚltima actualización: hace más de 30 días
    • Oferta promocionada
    Regulatory Affairs Manager (Hybrid)

    Regulatory Affairs Manager (Hybrid)

    Spectrum VascularBridgewater, NJ, US
    A tiempo completo
    Spectrum Vascular is an innovative medical device company focused on vascular access and medication management.Our mission is to improve the lives of patients worldwide by providing caregivers with...Mostrar másÚltima actualización: hace 11 días
    • Oferta promocionada
    Director, Regulatory Affairs Advertising & Promotion

    Director, Regulatory Affairs Advertising & Promotion

    NovartisEast Hanover, NJ, US
    A tiempo completo
    Director, Regulatory Affairs Advertising & Promotion.Novartis has an incredible opportunity for a talented individual to join our team as the Director, Regulatory Affairs Advertising & Promotion.Yo...Mostrar másÚltima actualización: hace más de 30 días