Regulatory Affairs Manager jobs in Illinois

Regulatory Affairs Manager manages regulatory matters and executes the strategy to ensure the organization complies with applicable regulations. Implements processes and systems to ensure that all necessary licensing, filings, certifications, and permits are processed and monitored. Being a Regulatory Affairs Manager utilizes established monitoring policies and procedures to ensure compliance with existing regulations. Anticipates new or changing regulations and coordinates with internal stakeholders to develop strategies to address changes in product, operations, or testing requirements. Additionally, Regulatory Affairs Manager investigates and addresses any reported issues of non-compliance. Requires a bachelor's degree. Typically reports to a director. The Regulatory Affairs Manager manages subordinate staff in the day-to-day performance of their jobs. True first level manager. Ensures that project/department milestones/goals are met and adhering to approved budgets. Has full authority for personnel actions. To be a Regulatory Affairs Manager typically requires 5 years experience in the related area as an individual contributor. 1 - 3 years supervisory experience may be required. Extensive knowledge of the function and department processes. (Copyright 2024 Salary.com)

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Regulatory Operations Submissions Manager - OneSource Regulatory
  • OneSource Regulatory
  • Chicago, IL FULL_TIME
  • Join the OSR Team to transform Regulatory Operations project submission management and the way you work.


    About OneSource Regulatory


    OneSource Regulatory™ helps companies implement the correct solutions, processes, standards, systems, templates, and best practices for effective Regulatory Operations.  With the right Regulatory Operations group, our clients can achieve high quality document management, data management, and regulatory agency submissions.


      Today we provide the following exemplary operations services:


    • Regulatory Operations service provider to over 100 small to large sized companies
    • Process Optimization
    • System Implementations
    • Document Management
    • Submission Management
    • Publishing
    • Archiving
    • RIM
    • Submission Managers
    • Publishers
    • Fully Outsourced Regulatory Operations


    Experience in pharmaceutical, biotechnology, medical device, nutritional supplements, animal health and cosmetic products


    Collaborative professionals who file applications for new brands as well as maintain growth and legacy products


    We hire the best, most experienced and collaborative experts in the industry and ensure that they have the latest resources and technology solutions.


    • Work from anywhere
    • Competitive salary & innovative incentive programs


    What You’ll Do


    Do you want the opportunity to work with a diverse group of pharmaceutical companies and provide publishing support for some of the most innovative products in the industry - from the comfort of your home?


    OneSource Regulatory (OSR), is seeking qualified Regulatory Operations Submission Management professionals based in the US.  You should be a collaborative team member who provides planning and execution of regulatory submissions (clinical trial applications, HA meeting packages, NDA/MAA) for several client products through effective interaction with submission teams, Regulatory Leads, and the OSR Regulatory Operations Director.  You should have a strong ability to work independently, with flexibility and a strong ability to connect and collaborate with clients and team members while working remotely.


    The OneSource Regulatory team is comprised of the top experts in Regulatory Operations.  OSR team members have an average of 15 years of industry experience in large, mid-size and small companies across every therapeutic area.


    At OSR, you will be offered interesting and challenging work, and your position will come with a competitive salary, a flexible schedule and innovative incentive programs that reward your contributions and innovations.  You will have the opportunity for personal and professional development through internal coaching and mentoring, in addition to the opportunity to attend key external events.


    Learn more about OSR by visiting our website:  www.OneSourceRegulatory.com


    Questions?  Email us at info@OneSourceRegulatory.com


     


    Interested in joining the OSR Team?  


     


    Provide your information through the BambooHR form below. 

  • 1 Month Ago

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Regulatory Operations Project Manager - OneSource Regulatory
  • OneSource Regulatory
  • Chicago, IL FULL_TIME
  • Join the OSR Team to transform Regulatory project management and the way you work. About OneSource Regulatory OneSource Regulatory™ helps companies implement the correct solutions, processes, standard...
  • 23 Days Ago

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Regulatory Affairs Manager
  • Inspira Financial
  • Brook, IL FULL_TIME
  • Take the next step in your journey at Inspira Financial. You will help businesses and individuals thrive today, tomorrow, and into retirement. Become part of a company that is people centric and clien...
  • 14 Days Ago

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Senior Manager, Regulatory Affairs
  • Sysmex America, Inc
  • Lincolnshire, IL FULL_TIME
  • Senior Manager, Regulatory Affairs Job Location(s) US-IL-Lincolnshire # of Openings 1 Job ID 2023-3713 Category Regulatory/Quality Travel 10% Overview Find a Better Way... ...to use your skills and ex...
  • 1 Day Ago

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Regulatory Affairs Manager (Remote)
  • Inspira Financial
  • Brook, IL FULL_TIME
  • Take the next step in your journey at Inspira Financial. You will help businesses and individuals thrive today, tomorrow, and into retirement. Become part of a company that is people centric and clien...
  • 8 Days Ago

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Senior Manager, Regulatory Affairs
  • Sysmex
  • Lincolnshire, IL OTHER
  • Overview Find a Better Way... ...to use your skills and experience. This is the time to let your talent come to life. To maximize your knowledge and use it for the greater good. To work with the best ...
  • 1 Month Ago

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Regulatory Affairs Manager
  • Ferris Mfg. Corp.
  • Fort Worth, TX
  • Ferris Mfg. Corp., a successful and long-established Medical Device Manufacturer, is seeking a responsible, self-motivat...
  • 4/19/2024 12:00:00 AM

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Regulatory Affairs Manager
  • Capstone Development Services Co, LLC
  • Rosemont, IL
  • Company Capstone, a fast-growing, private equity-owned pharmaceutical company; develops complex generic products, intern...
  • 4/19/2024 12:00:00 AM

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Regulatory Affairs Manager
  • Elliquence
  • Baldwin, NY
  • elliquence has a 50-year heritage of technological distinction and global presence in the fields of neurosurgery, endosc...
  • 4/19/2024 12:00:00 AM

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Regulatory Affairs Manager
  • Power Dream
  • Company Description Power Dream is a dedicated participant in the global Energy Curing industry, specializing in oligome...
  • 4/18/2024 12:00:00 AM

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Regulatory Affairs Manager
  • Akston Biosciences Corporation
  • Beverly, MA
  • Regulatory Affairs Manager Reporting Reports to VP, Quality Assurance and Regulatory Affairs Company Akston Biosciences ...
  • 4/16/2024 12:00:00 AM

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Regulatory Affairs Manager
  • Daikin Comfort
  • Waller, TX
  • Regulatory Affairs Manager Daikin Comfort Technologies Manufacturing, L.P. is seeking a skilled individual for our Regul...
  • 4/16/2024 12:00:00 AM

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Regulatory Affairs Manager
  • Akston Biosciences Corporation
  • Beverly, MA
  • Regulatory Affairs Manager Reporting Reports to VP, Quality Assurance and Regulatory Affairs Company Akston Biosciences ...
  • 4/15/2024 12:00:00 AM

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Regulatory Affairs Manager
  • Abbott Laboratories
  • Austin, TX
  • Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-chan...
  • 8/28/2023 12:00:00 AM

Illinois (/ˌɪlɪˈnɔɪ/ (listen) IL-ih-NOY) is a state in the Midwestern and Great Lakes region of the United States. It has the fifth largest gross domestic product (GDP), the sixth largest population, and the 25th largest land area of all U.S. states. Illinois is often noted as a microcosm of the entire United States. With Chicago in northeastern Illinois, small industrial cities and immense agricultural productivity in the north and center of the state, and natural resources such as coal, timber, and petroleum in the south, Illinois has a diverse economic base, and is a major transportation hu...
Source: Wikipedia (as of 04/11/2019). Read more from Wikipedia
Income Estimation for Regulatory Affairs Manager jobs
$140,928 to $198,786

Regulatory Affairs Manager in Wichita Falls, TX
Other names for this job might include Clinical Trials Systems Administrator, Global Regulatory Affairs Manager, Regulatory Administrator, Regulatory Affairs Director, Regulatory Affairs Manager, Regulatory Affairs Portfolio Leader, Regulatory Consultant, Regulatory Leader, Regulatory Process Manager, Regulatory Product Manager.
January 17, 2020
Regulatory Affairs Manager in Baltimore, MD
Lead strategic contributions and initiatives to develop regulatory services and improve current processes and procedures.
January 18, 2020
Regulatory Affairs Manager in Fort Lauderdale, FL
Regulatory Domain Support for business development, including solutioning and developing innovative solutions, creation of materials for and participation in sales pursuits, key client meetings, bid defences for RFIs and RFPs.
December 04, 2019