Demo

Regulatory Operations Associate

Technical Resources International
Bethesda, MD Full Time
POSTED ON 2/5/2025
AVAILABLE BEFORE 5/4/2025

Job Title

Regulatory Operations Associate

Location

Bethesda, MD 20817 US (Primary)

Category

Regulatory Affairs

Job Type

Full-Time

Salary Range

54,000.00-60,000.00 / YEAR

Education

Bachelor's Degree

Travel

None

Job Description

  • Prepare standard documentation supporting regulatory filings and distribution to stakeholders.
  • Utilize and maintain hard copy and electronic filing systems for auditable regulatory documents.
  • Maintain effective high-profile communications and interactions with colleagues, collaborators, and clients as appropriate.
  • Draft, edit, and distribute various documents as needed based on templates and work instructions.
  • Develop and maintain work process tools to promote efficiency and productivity. These may include templates, SOPs, work instructions, checklists, etc.
  • Track regulatory activity, maintain, and update databases, and ensure that records are complete and current.
  • Provide other administrative regulatory support as needed.

Job Requirements

  • Excellent oral and written communication skills; detail-oriented and able to multi-task / prioritize well.
  • Superior organizational skills and customer service abilities are required.
  • Experience publishing regulatory submissions using electronic submission software and proficiency in preparing documents that are compliant with electronic submission standards is preferred.
  • Proficiency in MS Office (Word, Excel, and Outlook); experience with SharePoint is a plus.
  • Must be able to exercise initiative and sound judgment, and to prioritize ongoing projects.
  • Familiarity with Good Clinical Practices and / or experience of working in an FDA-regulated environment is desirable.
  • General knowledge of the drug and vaccine development process or clinical trials is a plus.
  • We are equal opportunity / affirmative action employers, committed to diversity in the workplace. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, gender identity, sexual orientation, national origin, disability, or protected veteran status, or any other protected characteristic under state or local law.

    If your compensation planning software is too rigid to deploy winning incentive strategies, it’s time to find an adaptable solution. Compensation Planning
    Enhance your organization's compensation strategy with salary data sets that HR and team managers can use to pay your staff right. Surveys & Data Sets

    What is the career path for a Regulatory Operations Associate?

    Sign up to receive alerts about other jobs on the Regulatory Operations Associate career path by checking the boxes next to the positions that interest you.
    Income Estimation: 
    $115,103 - $147,076
    Income Estimation: 
    $157,066 - $200,252
    Income Estimation: 
    $140,918 - $196,956
    Income Estimation: 
    $188,947 - $264,846
    Income Estimation: 
    $176,359 - $246,541
    Income Estimation: 
    $158,728 - $233,218
    Income Estimation: 
    $63,371 - $83,018
    Income Estimation: 
    $77,272 - $101,684
    Income Estimation: 
    $78,084 - $104,270
    Income Estimation: 
    $75,043 - $100,052
    Income Estimation: 
    $78,084 - $104,270
    Income Estimation: 
    $95,800 - $126,196
    Income Estimation: 
    $97,803 - $128,184
    Income Estimation: 
    $95,508 - $129,349
    Income Estimation: 
    $97,803 - $128,184
    Income Estimation: 
    $122,529 - $166,597
    Income Estimation: 
    $123,229 - $164,502
    Income Estimation: 
    $123,155 - $167,827

    Sign up to receive alerts about other jobs with skills like those required for the Regulatory Operations Associate.

    Click the checkbox next to the jobs that you are interested in.

    • Compliance Management Skill

      • Income Estimation: $94,513 - $153,877
      • Income Estimation: $112,825 - $146,059
    • Cost Management Skill

      • Income Estimation: $102,134 - $138,385
      • Income Estimation: $111,271 - $144,173
    View Core, Job Family, and Industry Job Skills and Competency Data for more than 15,000 Job Titles Skills Library

    Job openings at Technical Resources International

    Technical Resources International
    Hired Organization Address Bethesda, MD Full Time
    Medical Writing Manager - (MGRMWI_COMPANY_1) Job Title : Medical Writing Manager Location : Bethesda, MD 20817 US (Prima...
    Technical Resources International
    Hired Organization Address Bethesda, MD Full Time
    Job Title Medical Writing Manager Location Bethesda, MD 20817 US (Primary) Category Medical Writing Job Type Full-Time S...
    Technical Resources International
    Hired Organization Address Bethesda, MD Full Time
    Associate Director, Clinical Operations - (ADCO_COMPANY_1.2) Job Title : Associate Director, Clinical Operations Locatio...
    Technical Resources International
    Hired Organization Address MD Full Time
    Job Title Regulatory Operations Associate Location Bethesda, MD 20817 US (Primary) Category Regulatory Affairs Job Type ...

    Not the job you're looking for? Here are some other Regulatory Operations Associate jobs in the Bethesda, MD area that may be a better fit.

    Associate Director, OCLO Operations

    Financial Industry Regulatory Authority , Inc., Rockville, MD

    Regulatory Operations Associate

    tech-res, Bethesda, MD

    AI Assistant is available now!

    Feel free to start your new journey!