Regulatory Affairs Manager jobs in Chicago, IL

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...
  • 28 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...
  • 19 Days Ago

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Regulatory Affairs Manager
  • Bel Brands USA
  • Chicago, IL FULL_TIME
  • Country: United StatesCity: ChicagoJob Family: Quality Regulations ExpertiseContract Type: Unlimited-termJob ID: 50311Regulatory Affairs ManagerBel, makers of iconic cheese brands including Babybel, T...
  • Just Posted

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Regulatory Affairs Manager
  • Bel Group
  • Chicago, IL FULL_TIME
  • Bel, makers of iconic cheese brands including Babybel, The Laughing Cow, and Boursin, is a growing global company that values your contributions, strives to create a sense of belonging for everyone an...
  • 1 Day 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...
  • 6 Days Ago

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0 Regulatory Affairs Manager jobs found in Chicago, IL area

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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...
  • 4/24/2024 12:00:00 AM

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Regulatory Affairs Manager - US
  • Aesku Inc
  • Des Plaines, IL
  • Introduction to AESKU:Headquartered in Wendelsheim, Germany, AESKU was founded by Dr. Torsten Matthias in 2000 to make a...
  • 4/24/2024 12:00:00 AM

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Regulatory Specialist - Food Manufacturing
  • Aegis Worldwide
  • Lincolnwood, IL
  • Job Description Job Description We are seeking a Regulatory Specialist to join the team at a food manufacturing company....
  • 4/24/2024 12:00:00 AM

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Senior Manager Regulatory Affairs - Combination Products
  • Nemera France Sas
  • Chicago, IL
  • Senior Manager Regulatory Affairs - Combination Products Full-timeEducation Level: Bachelor's DegreeLegal entity: Nemera...
  • 4/23/2024 12:00:00 AM

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Regulatory Affairs Manager
  • Capstone Development Services Co Llc
  • Des Plaines, IL
  • Company Capstone, a fast-growing, private equity-owned pharmaceutical company; develops complex generic products, intern...
  • 4/22/2024 12:00:00 AM

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Regulatory Affairs Manager
  • Dental Technologies Inc
  • Lincolnwood, IL
  • Job Description Job Description Job Title: Regulatory Affairs Manager Department: Quality Assurance Reports To: Vice Pre...
  • 4/21/2024 12:00:00 AM

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Senior Manager, Regulatory Affairs Advertising & Promotions
  • Xeris Pharmaceuticals, Inc.
  • Chicago, IL
  • Overview: The Senior Manager, Regulatory Affairs Advertising & Promotion is responsible for directing the regulatory asp...
  • 4/21/2024 12:00:00 AM

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Clinical Research Site Director - 225659
  • Medix™
  • Oak Park, IL
  • Clinical Research Site Director - Oak Park, IL Job Summary: We are seeking an experienced individual adept at overseeing...
  • 4/21/2024 12:00:00 AM

Chicago (/ʃɪˈkɑːɡoʊ/ (listen), locally also /-ˈkɔː-/), officially the City of Chicago, is the most populous city in Illinois, as well as the third most populous city in the United States. With an estimated population of 2,716,450 (2017), it is the most populous city in the Midwest. Chicago is the principal city of the Chicago metropolitan area, often referred to as Chicagoland, and the county seat of Cook County, the second most populous county in the United States. The metropolitan area, at nearly 10 million people, is the third-largest in the United States, and the fourth largest in North A...
Source: Wikipedia (as of 04/11/2019). Read more from Wikipedia
Income Estimation for Regulatory Affairs Manager jobs
$144,509 to $203,839
Chicago, Illinois area prices
were up 0.8% from a year ago

Regulatory Affairs Manager in Pittsfield, MA
The ideal candidate will have strong working knowledge of the agrochemical regulatory requirements.
December 24, 2019
Regulatory Affairs Manager in Stockton, CA
The world’s leading research-based pharmaceutical and healthcare companies is looking for a Regular Affairs Manager.
December 01, 2019
Regulatory Affairs Manager in Pierre, SD
Pharmaceutical companies, cosmetics manufacturers, food producers, and medical device suppliers hire regulatory affairs managers to make sure they adhere with all regulations.
February 01, 2020