Regulatory Relations Specialist jobs in Grand Forks, ND

Regulatory Relations Specialist files applications and interacts with governmental officials during the regulation and certification process for a plant or other facility. Assists in developing procedures to ensure regulatory compliance. Being a Regulatory Relations Specialist gathers data pertaining to organizational projects and their impact on the regulation process. May require a bachelor's degree. Additionally, Regulatory Relations Specialist typically reports to a supervisor or manager. To be a Regulatory Relations Specialist typically requires 4 to 7 years of related experience. Contributes to moderately complex aspects of a project. Work is generally independent and collaborative in nature. (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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Public Relations Director
  • SMP Health
  • Rolla, ND FULL_TIME
  • Public Relations Director Part-Time 24 hours a week We are currently taking application for a Part-time Public Relations Director
  • 10 Days Ago

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Manager, Employee Relations
  • Digi-Key Electronics
  • Thief River Falls, MN FULL_TIME
  • DigiKey is one of the fastest growing distributors of electronic components in the world. In addition to offering the broadest selection of in-stock electronic components and providing the best servic...
  • 16 Days Ago

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Regulatory Submissions (Study Start Up) Coordinator
  • Medpace, Inc.
  • Munich, ND OTHER
  • Job Summary As a Regulatory Submissions Coordinator you will have the opportunity to work within Regulatory Submissions, supporting our many projects and gaining some vital experience. You will be a p...
  • 24 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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Student Assistant—Marketing and Communications with a focus on alumni relations
  • Boston Consulting Group
  • Munich, ND TEMPORARY
  • As a Working Student, you’ll support our Marketing and Communications team, particularly in the area of alumni relations. You will gain interesting insights into our work with former employees and the...
  • 1 Month Ago

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0 Regulatory Relations Specialist jobs found in Grand Forks, ND area

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Admissions Liaison
  • Encompass Health
  • Grand Forks, ND
  • *Non-patient care, clinical administration *Licensure required Tremendous professional abilities Tremendous impact on pa...
  • 3/28/2024 12:00:00 AM

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Senior Occupational Therapist - Grand Forks
  • Sanford Health
  • Grand Forks, ND
  • Create Your Career With Us! Sanford Health is one of the largest and fastest-growing not-for-profit health systems in th...
  • 3/28/2024 12:00:00 AM

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Banquet Server|Part-time| Alerus Center
  • AEG
  • Grand Forks, ND
  • In order to be considered for this role, after clicking "apply now" above and being redirected, you must fully complete ...
  • 3/27/2024 12:00:00 AM

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Health Physicist
  • Department of Defense
  • Grand Forks, ND
  • Summary Click on "Learn more about this agency" button below for IMPORTANT additional information. This position will su...
  • 3/27/2024 12:00:00 AM

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Laboratory Supervisor - MLT or MT / CLS - Interim Assignment
  • Continuum Medical Staffing
  • Grand Forks, ND
  • Job Description Job Description Lab Supervisor needed to support hospital system in Grand Forks, NC. Housing, travel, be...
  • 3/27/2024 12:00:00 AM

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Clinical Nurse
  • Department of Defense
  • Grand Forks Afb, ND
  • Summary Click on "Learn more about this agency" button below for IMPORTANT additional information. This position will su...
  • 3/27/2024 12:00:00 AM

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Public Works Director
  • City of Hillsboro ND
  • Grand Forks, ND
  • Job Description Job Description We have an immediate opening for Public Works Director. You will be responsible for mana...
  • 3/26/2024 12:00:00 AM

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Site Safety Health Officer (SSHO)
  • Conti Federal Services
  • Grand Forks Afb, ND
  • This position does not require relocation, however, it requires rotational travel for a minimum of 3 weeks at a time, wi...
  • 3/26/2024 12:00:00 AM

Grand Forks is 74 miles (119 km) north of the Fargo-Moorhead area and 145 miles (233 km) south of Winnipeg, Manitoba. Grand Forks is on the western bank of the Red River of the North in an area known as the Red River Valley. The term "forks" refers to the forking of the Red River with the Red Lake River near downtown Grand Forks. According to the United States Census Bureau, the city has a total area of 20.09 square miles (52.03 km2), of which, 19.91 square miles (51.57 km2) is land and 0.18 square miles (0.47 km2) is water. Since it is in one of the flattest parts of the world, the city has f...
Source: Wikipedia (as of 04/11/2019). Read more from Wikipedia
Income Estimation for Regulatory Relations Specialist jobs
$66,666 to $91,521
Grand Forks, North Dakota area prices
were up 0.8% from a year ago

Regulatory Relations Specialist in Albany, GA
The Regulatory Relations Specialist is responsible for the execution of the overall strategy for regulatory engagement and enterprise-wide standards.  This includes assisting with the management of regulatory examinations, inquiries and meetings.  Additional responsibilities include.
December 09, 2019
Regulatory Relations Specialist in Monroe, LA
We are looking for a Marketing Specialist to plan, coordinate and manage marketing campaigns and activities across marketing channels.
February 06, 2020