Regulatory Affairs Manager jobs in Nebraska

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 – Biologics
  • Huvepharma
  • Lincoln, NE FULL_TIME
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    Provides extensive knowledge to ensure regulatory approvals in the US for veterinary biologicals and to ensure global registrations for veterinary biologicals are completed in accordance with the corporate strategy. Works on highly complex projects without supervision and assists less-experienced staff to perform critical functions within the department.

    EDUCATION AND EXPERIENCE

    • Bachelor’s degree required, Master’s Degree preferred, in Biology, Microbiology, or similar life sciences
    • 10-14 years’ relevant regulatory experience in either the veterinary biopharmaceutical or biologicals industry
    • More than 5 years’ leadership and project management experience
    • Established relationship with USDA CVB preferred

    TECHNICAL SKILLS REQUIREMENTS

    • Extensive knowledge of regulatory agencies and their mandates for approval of veterinary biological products in the US and other countries
    • Strong scientific and technical understanding of R&D processes, product development and licensing
    • Strong understanding of manufacturing and quality requirements, processes and compliance
    • Outstanding written and verbal communication skills, such as the need to understand, review and comment on scientific datasets, methods, and reports
    • Effectively collaborates, influences and builds trust across multiple disciplines and levels of the company
    • Strong positive negotiation skills
    • Strong project management and priority-setting skills
    • Ability to identify and resolve issues timely and pro-actively

    PHYSICAL REQUIREMENTS

    The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of the job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

    While performing the duties of this job, the employee sits most of the time. Ability to travel to various sites and to government meetings as required.

    POSITION RESPONSIBILITIES

    • Accountable for the timely creation, preparation and submission of registration documentation required for approval of new biological products in the US.
    • Accountable for the timely creation, preparation and submission of registration documentation required to ensure compliance to 9CFR regulations for all biological products.
    • Provide technical, strategic and tactical regulatory guidance to project teams and staff for development of new products and maintenance of existing products.
    • Communicates pertinent changes and updates to applicable project teams and senior management.
    • Negotiates and influences internal personnel and regulatory agencies (national and international) as needed to resolve key regulatory issues and expedite approvals of products.
    • Effectively participate with industry trade associations.
  • 13 Days Ago

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Regulatory Affairs Intern
  • National Indemnity Company
  • Omaha, NE INTERN
  • Company:BHHIC Berkshire Hathaway Homestate Insurance CompanyAs a member of the Berkshire Hathaway group of insurance companies, we offer outstanding opportunities for professionals interested in worki...
  • Just Posted

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Associate Director, Regulatory Affairs
  • Merck Sharp & Dohme
  • Elkhorn, NE FULL_TIME
  • Job Description Our Regulatory Affairs Team bring new medical advancements to the world by facilitating communications and procedures that allow swift, organized compliance partnering with external re...
  • Just Posted

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Regulatory Affairs Analyst
  • National Indemnity Company
  • Omaha, NE FULL_TIME
  • Company:BHHIC Berkshire Hathaway Homestate Insurance CompanyAs a member of the Berkshire Hathaway group of insurance companies, we offer outstanding opportunities for professionals interested in worki...
  • 15 Days Ago

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Executive Director, Advertising & Promotions Regulatory Affairs
  • Bausch Health
  • Omaha, NE FULL_TIME
  • Bausch Health is a global company that develops, manufactures, and markets a differentiated product portfolio across multiple high-growth therapeutic areas including Gastroenterology, Generics, Neurol...
  • 11 Days Ago

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Executive Director, Advertising & Promotions Regulatory Affairs
  • Bausch Health
  • Lincoln, NE FULL_TIME
  • Bausch Health is a global company that develops, manufactures, and markets a differentiated product portfolio across multiple high-growth therapeutic areas including Gastroenterology, Generics, Neurol...
  • 11 Days Ago

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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...
  • 3/28/2024 12:00:00 AM

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Regulatory Affairs Manager (Chemical Labeling)
  • Astrix
  • Countryside, IL
  • The Regulatory Labeling Manager develops, coordinates, and implements regulatory strategies for products that require go...
  • 3/28/2024 12:00:00 AM

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Regulatory Affairs Manager
  • Daikin Comfort
  • Waller, TX
  • Regulatory Affairs Manager Daikin Comfort Technologies Manufacturing, L.P. is seeking a skilled individual for our Regul...
  • 3/27/2024 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...
  • 3/27/2024 12:00:00 AM

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Global Regulatory Affairs Manager II
  • Yoh, A Day & Zimmermann Company
  • Fort Worth, TX
  • Job Description Job Description Global Regulatory Affairs Manager II - Fort Worth 9 month contract W2 Pay Rate: $55.00 -...
  • 3/27/2024 12:00:00 AM

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Regulatory Affairs Manager
  • Beacon Hill Staffing Group
  • San Fernando, CA
  • **Role is Fully Onsite to Northridge, CA** ROLE SUMMARY To support the our business in maintaining regulatory compliance...
  • 3/25/2024 12:00:00 AM

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Regulatory Affairs Manager
  • Advanced Respiratory Technologies, Inc.
  • Pittsburgh, PA
  • Advanced Respiratory Technologies, Inc. is a medical device company located outside of Pittsburgh, PA that is developing...
  • 3/25/2024 12:00:00 AM

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Regulatory Affairs Manager
  • Alameda Health System
  • Oakland, CA
  • Summary SUMMARY: Plans, coordinates, monitors compliance with federal, state and local regulations; manages accreditatio...
  • 3/25/2024 12:00:00 AM

The state is bordered by South Dakota to the north; Iowa to the east and Missouri to the southeast, across the Missouri River; Kansas to the south; Colorado to the southwest; and Wyoming to the west. The state has 93 counties and is split between two time zones, with the state's eastern half observing Central Time and the western half observing Mountain Time. Three rivers cross the state from west to east. The Platte River, formed by the confluence of the North Platte and the South Platte, runs through the state's central portion, the Niobrara River flows through the northern part, and the Rep...
Source: Wikipedia (as of 04/11/2019). Read more from Wikipedia
Income Estimation for Regulatory Affairs Manager jobs
$128,911 to $181,827

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