Regulatory Affairs Manager jobs in Pennsylvania

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
  • 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 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
  • 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...
  • 18 Days Ago

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Regulatory Affairs Manager III
  • Integrated Resources INC
  • Spring, PA FULL_TIME
  • Company DescriptionIntegrated Resources, Inc., is led by a seasoned team with combined decades in the industry. We deliver strategic workforce solutions that help you manage your talent and business m...
  • Just Posted

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Regulatory Affairs Manager
  • ICON plc
  • Blue Bell, PA FULL_TIME
  • At ICON, it’s our people that set us apart. Our diverse teams enable us to become a better partner to our customers and help us to fulfil our mission to advance and improve patients’ lives.Our ‘Own It...
  • 11 Days Ago

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Manager of Regulatory Affairs
  • Tyber Medical LLC
  • Bethlehem, PA FULL_TIME
  • DescriptionResponsible for managing the regulatory affairs activities throughout the organization. Manages and compiles regulatory submissions in the USA, EU and other jurisdictions as required. Requi...
  • 12 Days Ago

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Manager, Regulatory Affairs
  • Braeburn
  • Plymouth Meeting, PA FULL_TIME
  • Reports to: Senior Director, Regulatory AffairsLocation: RemoteCompany Overview:Braeburn is dedicated to delivering solutions for people living with the serious consequences of opioid use disorder. At...
  • 13 Days Ago

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Regulatory Affairs Manager
  • Mastech Digital
  • Oakland, CA
  • Position: HIM Director-Regulatory Affairs Manager Location: Oakland CA USA 94612 (5 days onsite) Duration: 12+ Months (P...
  • 6/12/2024 12:00:00 AM

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Regulatory Affairs Manager
  • SS White Dental
  • Lakewood, NJ
  • SS White Dental is seeking a Senior Regulatory Affairs Manager to support our Regulatory team. Candidates should have a ...
  • 6/12/2024 12:00:00 AM

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Regulatory Affairs Manager
  • JSHealth Vitamins
  • Los Angeles, CA
  • JSHealth Vitamins is seeking a Regulatory Affairs Manager to join our dynamic team in Westwood, Los Angeles. We are a le...
  • 6/12/2024 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...
  • 6/11/2024 12:00:00 AM

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Regulatory Affairs Manager
  • Catalyst Life Sciences
  • Chicago, IL
  • Opportunity to join a global diagnostics company at their HQ just outside of Chicago, focused on the strategy for existi...
  • 6/10/2024 12:00:00 AM

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Regulatory Affairs Manager
  • Blueroot Health™
  • PURPOSE STATEMENT: This position will be responsible for managing and coordinating implementation of regulatory requirem...
  • 6/10/2024 12:00:00 AM

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Regulatory Affairs Manager
  • Lumicity
  • This opportunity is with a company revolutionizing the medical device industry with its cutting-edge technologies and co...
  • 6/9/2024 12:00:00 AM

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Regulatory Affairs Manager
  • Tandym Group
  • Stamford, CT
  • Top hospital in Fairfield county, CT, just over the border from Westchester county NY, is seeking an experienced Regulat...
  • 6/8/2024 12:00:00 AM

Pennsylvania (/ˌpɛnsɪlˈveɪniə/ (listen) PEN-sil-VAY-nee-ə), officially the Commonwealth of Pennsylvania, is a state located in the northeastern and Mid-Atlantic regions of the United States. The Appalachian Mountains run through its middle. The Commonwealth is bordered by Delaware to the southeast, Maryland to the south, West Virginia to the southwest, Ohio to the west, Lake Erie and the Canadian province of Ontario to the northwest, New York to the north, and New Jersey to the east. Pennsylvania is the 33rd-largest state by area, and the 6th-most populous state according to the most recent of...
Source: Wikipedia (as of 04/11/2019). Read more from Wikipedia
Income Estimation for Regulatory Affairs Manager jobs
$138,191 to $194,920

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