Talent.com
Regulatory Specialist

Regulatory Specialist

ActalentPhiladelphia, PA, US
Hace 2 días
Tipo de contrato
  • A tiempo completo
Descripción del trabajo

Job Description

Job Description

Job Title : Regulatory Specialist

Job Description

As a Regulatory Specialist, you will be responsible for processing all initial regulatory documents for submission to Pharmaceutical Sponsors and Institutional Review Boards (IRB). You will also prepare and process required regulatory documentation through the IRB, CTSRMC, FDA, and other applicable regulatory review committees. This role involves working with pharmaceutical companies, contract research organizations (CROs), the NCI, and the FDA.

Responsibilities

  • Process initial regulatory documents for submission to Pharmaceutical Sponsors and IRB.
  • Prepare and process all regulatory documentation through the IRB, CTSRMC, FDA, and applicable regulatory review committees.
  • Prepare and process regulatory documentation for pharmaceutical companies, CROs, the NCI, and the FDA.

Essential Skills

  • Experience submitting to the IRB a minimum of 10 times.
  • Bachelor’s Degree with 2 to 5 years of experience or equivalent combination of education and experience.
  • 3 years of relevant experience in an academic regulatory environment.
  • IND / IDE / Clinical Trial Application experience.
  • Knowledge and experience with FDA Clinical Trial regulations and guidance.
  • Strong writing skills.
  • Ability to review and edit policies.
  • Ability to work in a team environment and independently.
  • Additional Skills & Qualifications

  • Experience with regulatory submission, document review, and compliance.
  • Knowledge of regulatory affairs and regulatory documents.
  • Experience with audits and regulatory compliance.
  • Work Environment

    This position offers a unique working environment within the city of Philadelphia. The role is 100% remote, with the requirement to reside in NJ, PA, or DE. Our Client provides an urban campus setting with easy access to educational, cultural, and recreational activities. Benefits include tuition reimbursement, a shutdown between Christmas and New Year’s Eve, great healthcare, flexible working hours, and paid holidays. The first few days may require equipment pick-up.

    Please send your resume and 2-3 professional references to hjaquez @actalentservices.com for next steps information.

    Job Type & Location

    This is a Contract to Hire position based out of Philadelphia, PA.

    Pay and Benefits

    The pay range for this position is $28.00 - $31.25 / hr.

    Eligibility requirements apply to some benefits and may depend on your job

    classification and length of employment. Benefits are subject to change and may be

    subject to specific elections, plan, or program terms. If eligible, the benefits

    available for this temporary role may include the following :

  • Medical, dental & vision
  • Critical Illness, Accident, and Hospital
  • 401(k) Retirement Plan – Pre-tax and Roth post-tax contributions available
  • Life Insurance (Voluntary Life & AD&D for the employee and dependents)
  • Short and long-term disability
  • Health Spending Account (HSA)
  • Transportation benefits
  • Employee Assistance Program
  • Time Off / Leave (PTO, Vacation or Sick Leave)
  • Workplace Type

    This is a hybrid position in Philadelphia,PA.

    Application Deadline

    This position is anticipated to close on Nov 17, 2025.

    About Actalent

    Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.

    The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

    If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options.

    Crear una alerta de empleo para esta búsqueda

    Regulatory Specialist • Philadelphia, PA, US

    Ofertas relacionadas
    • Oferta promocionada
    Regulatory Specialist

    Regulatory Specialist

    ChubbPhiladelphia, PA, US
    A tiempo completo
    This is the job title and description.No extra metadata, links, buttons, or any other unnecessary information has been included. The content is focused and clean, ensuring a high signal to noise rat...Mostrar másÚltima actualización: hace más de 30 días
    • Oferta promocionada
    Director, Global Medical and Promotional Regulatory Affairs

    Director, Global Medical and Promotional Regulatory Affairs

    Jazz PharmaceuticalsPhiladelphia, PA, US
    A tiempo completo
    If you are a current Jazz employee please apply via the Internal Career site.Jazz Pharmaceuticals is a global biopharma company whose purpose is to innovate to transform the lives of patients ...Mostrar másÚltima actualización: hace 2 días
    • Oferta promocionada
    Travel Physical Therapist (PT) - $1,820 to $3,000 per week in Egg Harbor Township, NJ

    Travel Physical Therapist (PT) - $1,820 to $3,000 per week in Egg Harbor Township, NJ

    AlliedTravelCareersEgg Harbor City, NJ, US
    A tiempo completo
    AlliedTravelCareers is working with CompHealth to find a qualified Physical Therapist (PT) in Egg Harbor Township, New Jersey, 08234!. Interested in this assignment? Or maybe you still have not foun...Mostrar másÚltima actualización: hace 4 días
    • Oferta promocionada
    Travel Physical Therapist (PT) - $1,940 per week in Egg Harbor Township, NJ

    Travel Physical Therapist (PT) - $1,940 per week in Egg Harbor Township, NJ

    AlliedTravelCareersEgg Harbor City, NJ, US
    A tiempo completo
    AlliedTravelCareers is working with Core Medical Group to find a qualified Physical Therapist (PT) in Egg Harbor Township, New Jersey, 08234!. Client in NJ seeking Physical Therapist : Outpatient / Cli...Mostrar másÚltima actualización: hace 4 días
    • Oferta promocionada
    • Nueva oferta
    Sr. Regulatory Specialist

    Sr. Regulatory Specialist

    Katalyst Healthcares & Life SciencesPhiladelphia, PA, US
    A tiempo completo
    Regulatory Specialist is responsible for supporting client product and product development and regulatory activities to commercialize new digital products, including AI technologies.Regulatory Spec...Mostrar másÚltima actualización: hace 17 horas
    • Oferta promocionada
    • Nueva oferta
    Manager, Regional Regulatory Lead LCM

    Manager, Regional Regulatory Lead LCM

    Pennsylvania StaffingKing Of Prussia, PA, US
    A tiempo completo
    CSL's R&D organization is accelerating innovation to deliver greater impact for patients.With a project-led structure and a focus on collaboration, we're building a future-ready team that thrives i...Mostrar másÚltima actualización: hace 17 horas
    • Oferta promocionada
    Associate Director, Regulatory Affairs (Remote)

    Associate Director, Regulatory Affairs (Remote)

    Jazz PharmaceuticalsPhiladelphia, PA, US
    Teletrabajo
    A tiempo completo
    If you are a current Jazz employee please apply via the Internal Career site.Jazz Pharmaceuticals is a global biopharma company whose purpose is to innovate to \ntransform the lives of patients and...Mostrar másÚltima actualización: hace 1 día
    Regional Regulatory Specialist

    Regional Regulatory Specialist

    Flourish ResearchPlymouth Meeting, PA, US
    A tiempo completo
    Quick Apply
    Flourish Research is looking for motivated, talented, creative individuals who want to learn and grow in their careers while contributing to research that changes lives! We offer an exc...Mostrar másÚltima actualización: hace más de 30 días
    • Oferta promocionada
    Associate Director, Global Regulator Strategy, Neuroscience

    Associate Director, Global Regulator Strategy, Neuroscience

    Bristol Myers SquibbPrinceton, NJ, US
    A tiempo completo
    Associate Director, Global Regulatory Strategy, Neuroscience.Those aren't words that are usually associated with a job.But working at Bristol Myers Squibb is anything but usual.Here, uniquely inter...Mostrar másÚltima actualización: hace más de 30 días
    • Oferta promocionada
    Procurement Specialist

    Procurement Specialist

    NDI Engineering CompanyPaulsboro, NJ, US
    A tiempo completo
    NDI is looking to add an a procurement specialist to our Thorofare, NJ team to support in locating key suppliers- such as machine shops and fabrication shops- negotiating the company’s purcha...Mostrar másÚltima actualización: hace 4 días
    • Oferta promocionada
    Executive Director, Medical Laboratory Technician

    Executive Director, Medical Laboratory Technician

    InsideHigherEdSewell, New Jersey, United States
    A tiempo parcial
    The Executive Director for the Medical Laboratory Technician program is responsible for developing the inaugural program. The Executive Director is responsible for all aspects of the medical laborat...Mostrar másÚltima actualización: hace más de 30 días
    • Oferta promocionada
    Regulatory Counsel

    Regulatory Counsel

    Beazley GroupPhiladelphia, PA, United States
    A tiempo completo
    Senior Regulatory Counsel - Licensing & Data Privacy.Regulatory and Compliance team, Underwriting, Partner Engagement, Claims. The position involves providing legal and regulatory support to Beazley...Mostrar másÚltima actualización: hace más de 30 días
    • Oferta promocionada
    Regulatory Specialist

    Regulatory Specialist

    Globus MedicalAudubon, PA, US
    A tiempo completo
    At Globus Medical, we move with a sense of urgency to deliver innovations that improve the quality of life of patients with musculoskeletal disorders. Our team is inspired by the needs of these pati...Mostrar másÚltima actualización: hace más de 30 días
    • Oferta promocionada
    Senior Regulatory Specialist_ Care / ACA- JHP

    Senior Regulatory Specialist_ Care / ACA- JHP

    JeffersonPhiladelphia, PA, US
    A tiempo completo
    The Regulatory Specialist is responsible for ensuring organizational compliance with federal and state regulatory requirements related to Medicare Advantage and ACA-compliant individual and small g...Mostrar másÚltima actualización: hace más de 30 días
    • Oferta promocionada
    Manager, Regulatory Affairs Submissions

    Manager, Regulatory Affairs Submissions

    J&J Family of CompaniesPhiladelphia, PA, US
    A tiempo completo
    Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the me...Mostrar másÚltima actualización: hace 3 días
    • Oferta promocionada
    Regulatory Associate

    Regulatory Associate

    Globus MedicalAudubon, PA, US
    A tiempo completo
    At Globus Medical, we move with a sense of urgency to deliver innovations that improve the quality of life of patients with musculoskeletal disorders. Our team is inspired by the needs of these pati...Mostrar másÚltima actualización: hace más de 30 días
    • Oferta promocionada
    R&A - Associate Principal Regulatory Writer (APRW) - Clinical

    R&A - Associate Principal Regulatory Writer (APRW) - Clinical

    Certara USA, Inc.Wayne, PA, United States
    A tiempo completo
    Certara (CERT) is the largest and most comprehensive provider of strategic drug development, modeling & simulation and regulatory science services. We partner with biopharmaceutical businesses to op...Mostrar másÚltima actualización: hace 16 días
    • Oferta promocionada
    Food Safety Technician

    Food Safety Technician

    Aspire BakeriesSwedesboro, NJ, US
    A tiempo completo
    Aspire Bakeries is a North American baking company with a leadership position in specialty frozen baked goods.Formed from leading bakery companies, its innovative food portfolio includes breads, ar...Mostrar másÚltima actualización: hace 6 días