Regulatory Affairs Manager jobs in Kentucky

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 Affairs Manager II
  • Planet Pharma
  • Oakbrook, KY FULL_TIME
  • Job Description

    Pay is commiserate with experience and ranges between $58-63/hr

    • Performs eCTD submission management across the product portfolio to global Health Authorities for both major submissions and lifecycle management.
    • The Global Delivery Manager is responsible for the coordination of all publishing deliverables, in line with the strategic direction of their assigned programs/products.
    • Oversee outsourced publishing deliverables on a day to day basis to ensure successful execution of operational activities for assigned products.
    • Acts as the primary point of contact for regulatory functions as appropriate in the products lifecycle. Partners with planning and tracking to ensure submission deliverables are incorporated and visible to all stakeholders.
    • Ensures hand offs and deliverables from authoring community are on time and in line with the submission standards and expectations of quality.
    • Drives deliverable timelines with RSM and authoring community and sets appropriate standards and expectations of quality. Identifies and assesses impact of agency guidance updates relevant to submission sciences, and drives innovative process change for improved efficiency.
    The Planet Group of Companies is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.
  • 3 Days Ago

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Regulatory Affairs Manager III - Part Time
  • Planet Pharma
  • Oakbrook, KY PART_TIME
  • Job DescriptionPay is commiserate with experience and ranges between $100-120/hrThis role is responsible for participating in cross-functional teams responsible for the development and life cycle mana...
  • 3 Days Ago

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Director, Regulatory and Scientific Affairs
  • CTI
  • Covington, KY FULL_TIME
  • Essential Functions: Primary responsibilities will include extensive writing of client deliverables to support agreed regulatory and clinical strategy. North American and EU experience is highly prefe...
  • Just Posted

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Director Regulatory Affairs
  • University of Kentucky
  • Lexington, KY FULL_TIME
  • Job Summary: The Director of Enterprise Regulatory Affairs will oversee and assure continued accreditation for the UK HealthCare Enterprise, coordinating and directing efforts related to The Joint Com...
  • 23 Days Ago

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Regulatory Affairs Specialist
  • BioPathogenix
  • Nicholasville, KY FULL_TIME
  • Company Description BioPathogenix specializes in molecular diagnostics for infectious disease testing. We offer a range of products, including multiplex qPCR reagents, attenuated pathogen quality cont...
  • 2 Months Ago

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Public Affairs Event Manager
  • Isaiah House Inc
  • Harrodsburg, KY FULL_TIME
  • DescriptionIsaiah House is looking for a dedicated and driven person to take on the role of Public Affairs Event Manager.Isaiah House is a faith-based, nonprofit with a competitive edge, delivering on...
  • 1 Day 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...
  • 6/2/2024 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 ...
  • 6/2/2024 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...
  • 6/2/2024 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...
  • 6/1/2024 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...
  • 5/31/2024 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...
  • 5/31/2024 12:00:00 AM

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Regulatory Affairs Manager
  • Formulated Solutions
  • Largo, FL
  • THE COMPANY: Formulated Solutions is redefining the Pharmaceutical and Self-Directed Consumer Healthcare CDMO experience...
  • 5/30/2024 12:00:00 AM

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Regulatory Affairs Manager
  • Procter & Gamble
  • Reading, England
  • Job Location Reading Job Description P&G is a leading global consumer goods company whose winning brands are Procter & G...
  • 5/22/2024 12:00:00 AM

Kentucky (/kənˈtʌki/ (listen) kən-TUK-ee), officially the Commonwealth of Kentucky, is a state located in the east south-central region of the United States. Although styled as the "State of Kentucky" in the law creating it, (because in Kentucky's first constitution, the name state was used) Kentucky is one of four U.S. states constituted as a commonwealth (the others being Virginia, Pennsylvania, and Massachusetts). Originally a part of Virginia, in 1792 Kentucky became the 15th state to join the Union. Kentucky is the 37th most extensive and the 26th most populous of the 50 United States. Ke...
Source: Wikipedia (as of 04/11/2019). Read more from Wikipedia
Income Estimation for Regulatory Affairs Manager jobs
$129,965 to $183,320

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