Regulatory Affairs Manager jobs in the United States

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
  • Boston, MA 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
  • Boston, MA 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...
  • 1 Month Ago

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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 solution...
  • 1 Month Ago

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Regulatory Operations Submissions Manager - OneSource Regulatory
  • OneSource Regulatory
  • Philadelphia, PA 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 solution...
  • 1 Month Ago

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Regulatory Operations Project Manager - OneSource Regulatory
  • OneSource Regulatory
  • Philadelphia, PA 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...
  • 17 Days 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...
  • 21 Days Ago

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Metrics Specialist - REMOTE
  • Net Health
  • Columbus, OH
  • About Net Health Belong. Thrive. Make a Difference. Are you looking for a meaningful and satisfying career where you hav...
  • 4/18/2024 12:00:00 AM

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Senior Consultant - Fire (Indiana, Kentucky, Ohio and Michigan)
  • TÜV SÜD
  • Columbus, OH
  • The Senior Consultant - Fire provides value-added consulting services to clients and meets the service guidelines stated...
  • 4/18/2024 12:00:00 AM

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Health Operations Data Analyst (NOT REMOTE)
  • Watts Healthcare Corporation
  • Columbus, OH
  • With over 50 years of service, our goal is to improve the health of the community we serve by creating easier access to ...
  • 4/17/2024 12:00:00 AM

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Columbus, OH - Senior Consultant - Technology Solutions Delivery Banking/Cap Mkts
  • Ernst & Young LLP
  • Columbus, OH
  • **Cookie information** Location: Grandview Heights * Engage with clients and project confidence when speaking * Demonstr...
  • 4/17/2024 12:00:00 AM

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Clinical Salesforce Business Analyst
  • Devfi
  • Columbus, OH
  • Title: Salesforce Business Analyst (Clinical) Duration: 12+ Months Location: Remote! Role Description: As a Clinical Sal...
  • 4/17/2024 12:00:00 AM

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Health Operations Data Analyst (NOT REMOTE)
  • Watts Healthcare Corporation
  • Columbus, OH
  • With over 50 years of service, our goal is to improve the health of the community we serve by creating easier access to ...
  • 4/16/2024 12:00:00 AM

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Metrics Specialist - REMOTE
  • Net Health
  • Columbus, OH
  • About Net Health Belong. Thrive. Make a Difference. Are you looking for a meaningful and satisfying career where you hav...
  • 4/16/2024 12:00:00 AM

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Trainer Geobox Driver
  • G&J Pepsi-Cola Bottlers Inc.
  • Columbus, OH
  • ** Trainer Geobox Driver** **** New **Summary:** In addition to established Geobox Driver responsibilities, the Trainer ...
  • 4/14/2024 12:00:00 AM

Income Estimation for Regulatory Affairs Manager jobs
$137,759 to $194,317