Regulatory Affairs Manager jobs in New Jersey

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 Project Manager - OneSource Regulatory
  • OneSource Regulatory
  • REMOTE, NJ 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, standards, systems, templates, and best practices for effective Regulatory Affairs.  With the right Regulatory Affairs group, our clients can achieve high quality strategies, 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 Project Management professionals based in the US.  You should be a collaborative team member who provides  planning and execution of Regulatory Affairs system and process project implementations for several client products through effective interaction with project teams, client project 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 Submissions Manager - OneSource Regulatory
  • OneSource Regulatory
  • REMOTE, NJ 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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Manager, Regulatory Affairs
  • Rocket Pharmaceuticals
  • Cranbury, NJ FULL_TIME
  • Work at ROCKET PHARMA and help cure rare diseases!Rocket Pharma is a fully integrated, clinical-stage company advancing gene therapies with curative potential for multiple rare childhood diseases. Roc...
  • 10 Days Ago

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Regulatory Affairs Manager - CANADA
  • Glenmark Pharmaceuticals Inc.
  • Mahwah, NJ FULL_TIME
  • POSITION DESCRIPTION Role / Position Title - Regulatory Affairs Manager - CANADA Country - Canada Region / City - Vaughan, Ontario FLSA (Exempt/Non-Exempt) - Exempt POSITION SUMMARY Reporting to the A...
  • 12 Days Ago

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Regulatory Affairs Manager
  • Ultimate
  • Princeton, NJ CONTRACTOR
  • Job Description Regulatory Affairs Manager Duration: 2 years; possibility of conversion to FTE (not guaranteed)Hourly Pay Rate: $60.00-$63.00/hourExpected Weekly Hours/Schedule: 40 hours Mon thru FriL...
  • 14 Days Ago

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Regulatory Affairs Manager
  • Katalyst Healthcares & Life Sciences
  • Madison, NJ CONTRACTOR
  • Responsibilities: This is not intended as a comprehensive list; it is intended to provide a representative summary of the major duties and responsibilities. Incumbent(s) may not be required to perform...
  • 1 Month Ago

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Regulatory Affairs Manager
  • Pharvaris
  • Boston, MA
  • Pharvaris is a late-stage biotech company developing bradykinin B2 receptor antagonists for bradykinin-mediated diseases...
  • 4/26/2024 12:00:00 AM

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Regulatory Affairs Manager
  • Kenvue
  • Skillman, NJ
  • Kenvue is currently recruiting for: Regulatory Affairs Manager This position reports to Director, Regulatory Affairsand ...
  • 4/26/2024 12:00:00 AM

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Regulatory Affairs Manager
  • Kenvue Inc.
  • Skillman, NJ
  • Kenvue is currently recruiting for: Regulatory Affairs Manager This position reports to Director, Regulatory Affairs and...
  • 4/26/2024 12:00:00 AM

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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...
  • 4/26/2024 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 ...
  • 4/25/2024 12:00:00 AM

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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...
  • 4/24/2024 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...
  • 4/24/2024 12:00:00 AM

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Regulatory Affairs Manager
  • Custom Search, Inc.
  • Minnetonka, MN
  • Our mid sized medical device client is adding a Manager Regulatory Affairs to the team. The Manager ensures compliance w...
  • 4/22/2024 12:00:00 AM

New Jersey is bordered on the north and northeast by New York (parts of which are across the Hudson River, Upper New York Bay, the Kill Van Kull, Newark Bay, and the Arthur Kill); on the east by the Atlantic Ocean; on the southwest by Delaware across Delaware Bay; and on the west by Pennsylvania across the Delaware River. New Jersey is often broadly divided into three geographic regions: North Jersey, Central Jersey, and South Jersey. Some New Jersey residents do not consider Central Jersey a region in its own right, but others believe it is a separate geographic and cultural area from the Nor...
Source: Wikipedia (as of 04/11/2019). Read more from Wikipedia
Income Estimation for Regulatory Affairs Manager jobs
$150,984 to $212,972

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