Talent.com
Regulatory Affairs Associate I
Regulatory Affairs Associate IUS Tech Solutions, Inc. • Florham Park, NJ, US
Regulatory Affairs Associate I

Regulatory Affairs Associate I

US Tech Solutions, Inc. • Florham Park, NJ, US
[job_card.variable_hours_ago]
[job_preview.job_type]
  • [job_card.temporary]
[job_card.job_description]

Duration : 12+ months contract

Job Description :

  • The Associate, Regulatory Affairs Submission Management , manages low to medium impact submission projects involving multiple cross-functional regulatory submission teams . With input from the submission teams, this individual establishes and maintains submission content planners and associated timelines , facilitates tactical submission team meetings, prepares content planners for publishing, interfaces with publishing vendor, and fulfills Submission Management functions on Project Teams in support of Development, Marketing, and post-marketing regulatory authority applications. This individual is recognized as a very knowledgeable in their discipline expert and in regulatory affairs submission management.

Responsibilities :

  • Manages low to medium impact (with respect to internal visibility, risk, complexity and criticality) submission projects to ensure the timely delivery of high quality dossiers that meet technical specifications defined by regulatory authorities and can be easily navigated and reviewed by a regulatory agency.
  • Acts as RA Submissions support to project teams providing guidance and communication of established submission processes and standards. Provides input to project publishing timelines and deliverables.
  • Participates in submission team meetings . Expedites, manages, and coordinates multiple concurrent interrelated activities for submission projects in the delivery of low to moderately complex published submissions within the required timelines. Anticipates obstacles and proposes solutions within the team.
  • Coordinates submission publishing with offsite publishers / provides notification to ensure all required resources are available to meet submission timelines. Prepares content planner for publishing and works with vendor to resolve publishing issues. May perform in-house publishing tasks
  • Facilitates the creation or procurement of submission content deliverables such as cover letters and forms
  • Performs detailed quality reviews of published output to ensure compliance with Regulatory Standards and Health Authority guidance’s including verification of content, bookmarks, hypertext links and tables of content in low to moderately complex submissions. Facilitates team reviews.
  • Contributes to the development of optimal business processes and standards within the department to ensure high levels of customer support and to achieve high quality submissions.
  • Contributes to the implementation of internal process and standards documents relating to publishing and publishing deliverables.
  • Suggests and contributes to process improvements, including changes to software and business processes. May participate on internal project teams to update business software.
  • Demonstrates ability to influence without direct authority. Builds and maintains positive relationships internally and externally.
  • Position accountability / scope : Supervision required. Receives project assignments from manager but has responsibility for managing own projects with oversight. Reviews project progress with manager on a regular basis with direction provided by manager. May assist with onboarding staff.

    • Experience :

  • Required Experience : Two years pharmaceutical or industry related experience
  • P referred experience : Publishing related software tools e.g. Documentum, eCTDXPress / ISIPublisher, ISI Toolbox / DocuBridge / Insight platform, Adobe Acrobat .
  • NOTE : Higher education may compensate for years of experience. Years of experience may also compensate for lower education

    • Skills :

  • Regulatory Affairs, Documentum, eCTDXPress / ISIPublisher, ISI Toolbox / DocuBridge / Insight platform, Adobe Acrobat.

    • Education :

  • Bachelor’s Degree

    • About US Tech Solutions :

    US Tech Solutions is a global staff augmentation firm providing a wide range of talent on-demand and total workforce solutions. To know more about US Tech Solutions, please visit

    www.ustechsolutions.com

    US Tech Solutions is an Equal Opportunity Employer.  All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.

    [job_alerts.create_a_job]

    Regulatory Associate • Florham Park, NJ, US

    [internal_linking.similar_jobs]
    Sr Associate, Regulatory Affairs, CMC

    Sr Associate, Regulatory Affairs, CMC

    Tonix Pharmaceuticals Inc • Chatham, NJ, US
    [job_card.full_time]
    Tonix is a fully integrated biotechnology company, publicly traded on NASDAQ (ticker : TNXP), with marketed products and a pipeline of development candidates The Company is focused on commercializin...[show_more]
    [last_updated.last_updated_30] • [promoted]
    Jurisdictional Consultant

    Jurisdictional Consultant

    FM • PARSIPPANY, New Jersey, United States
    [job_card.full_time]
    For nearly two centuries, FM clients have relied on our unmatched expertise in crafting engineering-driven risk management solutions. FM is the world's largest commercial property insurance and risk...[show_more]
    [last_updated.last_updated_30] • [promoted]
    Physician Rheumatology - Competitive Salary

    Physician Rheumatology - Competitive Salary

    Summit Recruiting Group • Freehold, NJ, US
    [job_card.full_time] +1
    Rheumatology Opportunity in Freehold, NJ.Located 40 miles from New York City; 20 miles from New Brunswick, NJ •New Grads & experienced candidates welcome •. H1 visa candidates welcome to apply.Pot...[show_more]
    [last_updated.last_updated_variable_hours] • [promoted] • [new]
    Principal Specialist, Global Labeling Regulatory

    Principal Specialist, Global Labeling Regulatory

    ImmunityBio • Summit, NJ, United States
    [job_card.full_time]
    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 ...[show_more]
    [last_updated.last_updated_30] • [promoted]
    Global Pharmacovigilance : Signal Manager

    Global Pharmacovigilance : Signal Manager

    Zoetis, Inc • Parsippany-Troy Hills, NJ, United States
    [job_card.full_time]
    We are seeking a veterinary professional with strong global regulatory expertise to join our Global Pharmacovigilance team, ensuring rigorous post-marketing surveillance of veterinary medicinal pro...[show_more]
    [last_updated.last_updated_30] • [promoted]
    Regulatory Affairs Associate

    Regulatory Affairs Associate

    The Fountain Groups • Florham Park, NJ, US
    [job_card.full_time]
    BS / MS in science Background or MS in Regualtory Affairs and 1+ year of expereince within the pharmaceutical industry as a Regulatory Affairs professional. Publishing related software tools e.Documen...[show_more]
    [last_updated.last_updated_1_day] • [promoted]
    Senior Manager, Regulatory Ad / Promo

    Senior Manager, Regulatory Ad / Promo

    Novartis Group Companies • East Hanover, NJ, United States
    [job_card.full_time]
    The Senior Manager, Regulatory Ad Promo will work under supervision to provide strategic regulatory advice on.US organization for assigned products in accordance with business goals and objectives,...[show_more]
    [last_updated.last_updated_1_day] • [promoted]
    Travel Laboratory Operations Manager

    Travel Laboratory Operations Manager

    PRIDE Health • Pompton Plains, NJ, US
    [job_card.full_time]
    PRIDE Health is seeking a travel Medical Technologist for a travel job in Pompton Plains, New Jersey.Job Description & Requirements. Under the direction of the Laboratory Director, the Manager, ...[show_more]
    [last_updated.last_updated_30] • [promoted]
    Senior Tax Associate - National Office (JD Required)

    Senior Tax Associate - National Office (JD Required)

    EisnerAmper • Iselin, NJ, United States
    [job_card.full_time]
    At EisnerAmper, we look for individuals who welcome new ideas, encourage innovation, and are eager to make an impact.Whether you're starting out in your career or taking your next step as a seasone...[show_more]
    [last_updated.last_updated_30] • [promoted]
    Senior Project Toxicologist / Scientific Lead

    Senior Project Toxicologist / Scientific Lead

    Zoetis, Inc • Parsippany-Troy Hills, NJ, United States
    [job_card.full_time]
    Zoetis Veterinary Medicine Research and Development (VMRD) is seeking a highly accomplished Sr.Project Toxicologist to join the Toxicology group within Clinical Pharmacology and Safety Sciences in ...[show_more]
    [last_updated.last_updated_30] • [promoted]
    Travel Director - Clinical Lab Scientist (CLS)

    Travel Director - Clinical Lab Scientist (CLS)

    Integrated Healthcare Services • Pompton Plains, NJ, US
    [job_card.full_time]
    Integrated Healthcare Services is seeking a travel Clinical Lab Scientist (CLS) Director for a travel job in Pompton Plains, New Jersey. Job Description & Requirements.Under the direction of the...[show_more]
    [last_updated.last_updated_variable_days] • [promoted]
    Radioligand Therapies (RLT) Associate Director, Priority Accounts - Pennsylvania

    Radioligand Therapies (RLT) Associate Director, Priority Accounts - Pennsylvania

    Novartis Group Companies • East Hanover, NJ, United States
    [job_card.full_time]
    This is a field-based and remote opportunity supporting key accounts in an assigned geography.Novartis is unable to offer relocation support for this role. Please only apply if this location is acce...[show_more]
    [last_updated.last_updated_variable_days] • [promoted]
    CADC Intern

    CADC Intern

    Morris County Aftercare Center • Denville, NJ, US
    [job_card.full_time]
    Are you currently taking classes to become a counselor, or have already completed your classes, but looking for supervision hours and seeking a career that makes a real difference? Join Morris Coun...[show_more]
    [last_updated.last_updated_30] • [promoted]
    Regulatory Affairs Associate I

    Regulatory Affairs Associate I

    US Tech Solutions • Florham Park, NJ, US
    [job_card.temporary]
    Associate, Regulatory Affairs Submission Management.Job Description : The associate, regulatory affairs submission management, manages low to medium impact submission projects involving multiple cro...[show_more]
    [last_updated.last_updated_1_day] • [promoted]
    Senior Manager, Regulatory Affairs (Biosimilars)

    Senior Manager, Regulatory Affairs (Biosimilars)

    Fresenius Kabi USA, LLC • Newark, NJ, United States
    [job_card.full_time]
    The Senior Manager, Regulatory Affairs delivers Regulatory Affairs and compliance guidance and strategic input as a subject matter expert in Biosimilar Development and Life Cycle Management to find...[show_more]
    [last_updated.last_updated_30] • [promoted]
    Regulatory Affairs Program Manager

    Regulatory Affairs Program Manager

    ImmunityBio • Summit, NJ, United States
    [job_card.full_time]
    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 ...[show_more]
    [last_updated.last_updated_variable_days] • [promoted]
    Travel Laboratory Operations Manager

    Travel Laboratory Operations Manager

    Access Healthcare • Pompton Plains, NJ, US
    [job_card.full_time]
    Access Healthcare is seeking a travel Medical Technologist for a travel job in Pompton Plains, New Jersey.Job Description & Requirements. Under the direction of the Laboratory Director, the Mana...[show_more]
    [last_updated.last_updated_30] • [promoted]
    Regulatory Affairs Associate

    Regulatory Affairs Associate

    Synectics Inc • Florham Park, NJ, US
    [job_card.full_time]
    The Associate, Regulatory Affairs Submission Management, manages low to medium impact submission projects involving multiple cross-functional regulatory submission teams. With input from the submiss...[show_more]
    [last_updated.last_updated_variable_days] • [promoted]