Regulatory Affairs Manager jobs in Arlington, MA

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
  • 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, 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. 

  • 7 Days Ago

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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 solution...
  • 9 Days Ago

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Senior Manager, Regulatory Affairs
  • Relay Therapeutics
  • Cambridge, MA FULL_TIME
  • The Opportunity: We are looking for a strategic regulatory leader to join our growing regulatory team at Relay Tx. You will have the opportunity to ​help define and implement innovative regulatory str...
  • 6 Days Ago

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Manager, Regulatory Affairs
  • Viridian Therapeutics, Inc
  • Waltham, MA FULL_TIME
  • Description At Viridian (NASDAQ: VRDN), we aim to advance new treatments for patients underserved by today’s therapies. Our team consists of talented, entrepreneurial-minded professionals dedicated to...
  • 19 Days Ago

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Manager, Regulatory Affairs CMC
  • Takeda Pharmaceutical
  • Boston, MA FULL_TIME
  • By clicking the “Apply” button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda...
  • 2 Months Ago

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Manager Regulatory Affairs-CMC
  • Integrated Resources INC
  • Lexington, MA FULL_TIME
  • Company DescriptionIntegrated Resources, Inc is a premier staffing firm recognized as one of the tri-states most well-respected professional specialty firms. IRI has built its reputation on excellent ...
  • 2 Months Ago

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0 Regulatory Affairs Manager jobs found in Arlington, MA area

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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 ...
  • 5/10/2024 12:00:00 AM

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Strategic Operations Manager
  • The Judge Group
  • Boston, MA
  • About the Job The Manager, Strategic Operations is responsible for the development, implementation, user training, and c...
  • 5/10/2024 12:00:00 AM

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Senior Manager Regulatory Affairs, Strategy
  • Inozyme Pharma
  • Boston, MA
  • Senior Manager/Associate Director, Regulatory Strategy Company Overview: Inozyme Pharma, Inc. (Nasdaq: INZY) is a clinic...
  • 5/9/2024 12:00:00 AM

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Regulatory Management Services, VP
  • State Street Corporation
  • Quincy, MA
  • As FLRC VP you will. Work within the Global Technology Services FLRC team to drive execution of organizational risk mana...
  • 5/9/2024 12:00:00 AM

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Senior Medical Director
  • Relay Therapeutics
  • Cambridge, MA
  • As a Senior Medical Director at Relay Tx, you will help advance our clinical pipeline from IND to proof of concept to re...
  • 5/8/2024 12:00:00 AM

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Regulatory Manager
  • BostonGene
  • Waltham, MA
  • Position Summary BostonGene is seeking a Regulatory Manager to join our team and play a crucial role in supporting our I...
  • 5/7/2024 12:00:00 AM

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Regulatory Affairs Operations Specialist, Ad/Promo (Remote)
  • Ardelyx
  • Waltham, MA
  • Description Ardelyx was founded with a mission to discover, develop and commercialize innovative, first-in-class medicin...
  • 5/7/2024 12:00:00 AM

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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...
  • 5/6/2024 12:00:00 AM

Arlington is a town in Middlesex County, Massachusetts, United States, six miles (10 km) northwest of Boston. The population was 42,844 at the 2010 census. Arlington covers 3,517.5 acres (14 km2), or 5.5 square miles, of which 286.2 acres (1.2 km2) are covered by water. There are 210.52 acres (0.9 km2) of parkland. Elevation ranges from 4 feet (1.2 m) above sea level (along Alewife Brook) to 377 feet (114.9 m) near Park Avenue and Eastern Avenue. Arlington borders on the Mystic Lakes, Mystic River, and Alewife Brook. Within its borders are Spy Pond, the Arlington Reservoir, Mill Brook, and Hil...
Source: Wikipedia (as of 04/11/2019). Read more from Wikipedia
Income Estimation for Regulatory Affairs Manager jobs
$154,825 to $218,387
Arlington, Massachusetts area prices
were up 2.5% 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