Regulatory Affairs Specialist jobs in North Dakota

Regulatory Affairs Specialist supports the oversight of regulatory matters and strategy implementation to ensure the organization complies with applicable regulations. Prepares filings and tracks applications for licensing, certification, and permits and interacts with governmental officials during the regulation and certification process. Being a Regulatory Affairs Specialist monitors compliance with existing regulations and upcoming or changing regulations. Performs impact analysis of regulatory changes and produces status reports. Additionally, Regulatory Affairs Specialist participates in processes to report, investigate, and addresses any issues of non-compliance. Typically requires a bachelor's degree. Typically reports to a supervisor or manager. The Regulatory Affairs Specialist occasionally directed in several aspects of the work. Gaining exposure to some of the complex tasks within the job function. To be a Regulatory Affairs Specialist typically requires 2 -4 years of related experience. (Copyright 2024 Salary.com)

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Regulatory Submissions Technical Advisor (Regulatory Affairs, Study Start-up)
  • Medpace, Inc.
  • Munich, ND OTHER
  • Job Summary

    Our clinical operations activities are growing rapidly and we are currently seeking full-time, Regulatory Submissions Technical Advisors to join our Site Activation and Maintenance team, within Clinical Operations.

     

    This position plays a key role at Medpace, preparing and reviewing regulatory documents and providing strategic regulatory advice to support clinical trial submissions. Medpace specialises in supporting mid-sized biopharma companies giving you the opportunity to work on complex and challenging trials, often involving new technologies and novel therapies.

     

    If you want an exciting role where you use your previous expertise and can develop and grow your career even further, then this is the opportunity for you. 

    Responsibilities

    • Provide regulatory submissions strategic advice and guidance to the Regulatory Submissions Manager (RSM), Medpace project team and Sponsor to ensure submissions compliance with appropriate regulations and requirements;
    • Prepare and/or review core trial documents for compliance with relevant guidelines/regulations and for trial suitability;
    • Prepare and maintain Part I EU CTR submissions
    • Review pertinent regulations and guidance to develop proactive solutions to regulatory issues and challenges;
    • Independently interact with Sponsors, regulatory agencies and Medpace colleagues; and
    • Present during bid defences, general capabilities meetings and audits, as required.

    Qualifications

    • Bachelor’s degree in Life Sciences – Master’s/PhD preferred;
    • Significant experience in regional/global regulatory submissions;
    • Strong understanding of regulatory documentation, guidelines and legislation;
    • Ability to review regulatory guidance and develop proactive solutions to regulatory issues and challenges;
    • Experience in reviewing and/or writing core regulatory documents;
    • Strong communication, critical thinking and problem-solving skills;
    • Ability to independently interact with national/regional regulatory agencies.

    Medpace Overview

    Medpace is a full-service clinical contract research organization (CRO). We provide Phase I-IV clinical development services to the biotechnology, pharmaceutical and medical device industries. Our mission is to accelerate the global development of safe and effective medical therapeutics through its scientific and disciplined approach. We leverage local regulatory and therapeutic expertise across all major areas including oncology, cardiology, metabolic disease, endocrinology, central nervous system, anti-viral and anti-infective. Headquartered in Cincinnati, Ohio, employing more than 5,000 people across 40 countries.

    Why Medpace?

    People. Purpose. Passion. Make a Difference Tomorrow. Join Us Today.

     

    The work we’ve done over the past 30 years has positively impacted the lives of countless patients and families who face hundreds of diseases across all key therapeutic areas. The work we do today will improve the lives of people living with illness and disease in the future.

     

    Medpace Perks

    • Hybrid work-from-home options (dependent upon position and level)
    • Competitive PTO packages
    • Company-sponsored employee appreciation events
    • Employee health and wellness initiatives
    • Flexible work schedule
    • Competitive compensation and benefits package
    • Structured career paths with opportunities for professional growth

    Awards

    • Recognized by Forbes as one of America's Best Mid-size Companies in 2021, 2022 and 2023
    • Continually recognized with CRO Leadership Awards from Life Science Leader magazine based on expertise, quality, capabilities, reliability, and compatibility

     

    What to Expect Next

    A Medpace team member will review your qualifications and, if interested, you will be contacted with details for next steps.

     

    EO/AA Employer M/F/Disability/Vets

     

  • 24 Days Ago

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Executive Director, Advertising & Promotions Regulatory Affairs
  • Bausch Health
  • Fargo, ND 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 (m/f/d)
  • Argenta
  • Munich, ND FULL_TIME
  • At Argenta, we're more than a company — we're a global team, dedicated to healthier animals. As the world’s only animal health contract research, development and manufacturing organisation (CRO/CDMO),...
  • 1 Month Ago

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Public Affairs Specialist
  • Natural Resources Conservation Service
  • Bismarck, ND FULL_TIME
  • This incumbent supports the Public Affairs Program of State Offices by planning and carrying out information and public affairs activities in the assigned work area.
  • 16 Days Ago

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Wildland Firefighter - Direct Hire Authority
  • US Interior, Bureau of Indian Affairs
  • Fort Yates, ND OTHER
  • Duties Serves as a trained member of a wildland fire module or hand crew or engine crew executing fuels management, fire suppression, monitoring, and post-fire activities. Specific specialty areas of ...
  • 6 Days Ago

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Fire Logistics Dispatcher
  • US Interior, Bureau of Indian Affairs
  • Belcourt, ND FULL_TIME
  • Duties Coordinates with other dispatch organizations on mobilization, reassignment, and demobilization of resources. Operates and/or directs the operation of various dispatch telecommunications system...
  • 1 Month Ago

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Regulatory Affairs Specialist
  • Katalyst Healthcares & Life Sciences
  • Athens, GA
  • Responsibilities: Collect and coordinate information and prepare regulatory documentation for submission to regulatory a...
  • 3/29/2024 12:00:00 AM

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Regulatory Affairs Specialist
  • Sterling Engineering
  • Addison, IL
  • Title: Regulatory Affairs Specialist Location: Schaumburg, IL Hire Type: Direct Hire Overview: Sterling has helped build...
  • 3/29/2024 12:00:00 AM

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Regulatory Affairs Specialist
  • Sally Beauty Holdings, Inc.
  • Denton, TX
  • Review labels of private label products for regulatory compliance in the US and applicable international markets. Review...
  • 3/28/2024 12:00:00 AM

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Regulatory Affairs Specialist
  • Katalyst Healthcares & Life Sciences
  • Tampa, FL
  • Responsibilities: Contributes to the FDA regulatory submission process; may aid in authoring and/or publishing electroni...
  • 3/28/2024 12:00:00 AM

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Regulatory Affairs Specialist
  • ConvaTec
  • Lexington, MA
  • Product Regulatory Affairs work includes: Directing submission development of product registration, progress reports, su...
  • 3/28/2024 12:00:00 AM

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Regulatory Affairs Specialist
  • Planet Pharma
  • Immediate need for Regulatory Affairs Specialist with a Clinical Research Organization in Raleigh. Hybrid position - wil...
  • 3/27/2024 12:00:00 AM

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Regulatory Affairs Specialist
  • Akkodis
  • Irvine, CA
  • Akkodis is seeking an Regulatory Affairs Specialist for a company located in Candidates need to be local to a Irvine ,CA...
  • 3/26/2024 12:00:00 AM

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Regulatory Affairs Specialist
  • Tephra
  • Edison, NJ
  • Description: The candidates will work with client & Our client's teams to deliver best in-class solutions for regulatory...
  • 3/26/2024 12:00:00 AM

North Dakota is a Midwestern state of the United States. It borders Canada and lies at the center of the North American continent. The geographic center of North America is near the town of Rugby. Bismarck is the capital of North Dakota, and Fargo is the largest city. Soil is North Dakota's most precious resource. It is the base of the state's great agricultural wealth. But North Dakota also has enormous mineral resources. These mineral resources include billions of tons of lignite coal. In addition, North Dakota has large oil reserves. Petroleum was discovered in the state in 1951 and quickly...
Source: Wikipedia (as of 04/11/2019). Read more from Wikipedia
Income Estimation for Regulatory Affairs Specialist jobs
$72,686 to $97,410

Regulatory Affairs Specialist in Petaluma, CA
The regulatory affairs industry plays an important role in ensuring the safety of countless products that Americans use every day—from food and beverages to pharmaceuticals and medical devices to electronics and more.
February 02, 2020
Becoming a regulatory affairs specialist is one of the most common ways to break into the industry.
February 10, 2020
Regulatory Affairs Specialist in Boulder, CO
They often advise project teams on subjects such as premarket regulatory requirements, export and labeling requirements, or clinical study compliance issues.
February 03, 2020
Regulatory Affairs Specialist in Concord, NH
Are you working as a Regulatory Affairs Specialist? Help us rate Regulatory Affairs Specialist as a Career.
December 31, 2019