Global Regulatory Submissions Specialist

Course Advisor

United States

On-site

USD 70,000 - 100,000

Full time

14 days+
Application generator

An application made for this job — a tailored resume and cover letter that speak straight to the posting.

Get past ATS filters

Job summary

Course Advisor is seeking a Regulatory Affairs Specialist to coordinate and document internal regulatory processes such as audits and license renewals. Responsibilities include recommending changes to procedures based on regulations, advising project teams on compliance, and preparing regulatory submissions. The role requires strong skills in active listening, writing, and critical thinking. Proficiency in tools like Microsoft Excel, Word, and SAP is preferred. This position is located in the United States and offers opportunities for professional growth.

Responsibilities

  • Recommend changes to company procedures in response to changes in regulations or standards.
  • Prepare additional information or responses as requested by regulatory agencies.
  • Advise project teams on regulatory requirements and compliance issues.
  • Provide technical review of reports for regulatory submissions.
  • Coordinate regulatory submissions for projects.
  • Interpret and communicate regulatory rules and changes.

Skills

Active Listening
Writing
Speaking
Reading Comprehension
Judgment and Decision Making
Critical Thinking

Tools

Microsoft Excel
Microsoft Word
Microsoft Office
Microsoft PowerPoint
Microsoft Outlook
Web browser software
Microsoft Access
SAP
Microsoft Project
Adobe Acrobat
Microsoft Visio
Microsoft SharePoint
SQL
Microsoft Dynamics
FileMaker Pro
Microsoft SQL Server
LexisNexis
Medical procedure coding software
MicroStrategy
QlikView

Job description

Course Advisor is seeking a Regulatory Affairs Specialist to coordinate and document internal regulatory processes such as audits and license renewals. Responsibilities include recommending changes to procedures based on regulations, advising project teams on compliance, and preparing regulatory submissions. The role requires strong skills in active listening, writing, and critical thinking. Proficiency in tools like Microsoft Excel, Word, and SAP is preferred. This position is located in the United States and offers opportunities for professional growth.
Get your free, confidential resume review.
or drag and drop your file here.
Similar jobs

Similar jobs worth comparing

Global Regulatory Submissions Specialist
Global Regulatory Submissions Specialist

Net2Source (N2S) • San Diego (CA)

On-site
USD 125,000 - 150,000
Regulatory Submissions Pro – Associate (Contract)
Regulatory Submissions Pro – Associate (Contract)

Indotronix Avani Group • Irvine (CA)

On-site
USD 65,000 - 90,000
Regulatory Affairs Specialist III – Global Submissions
Regulatory Affairs Specialist III – Global Submissions

Integrated Resources Inc. • Milwaukee (WI)

On-site
USD 65,000 - 85,000
Global Regulatory Submissions Publisher
Global Regulatory Submissions Publisher

Artech Information System LLC • Bridgewater (MA)

On-site
USD 70,000 - 90,000
Regulatory Affairs Specialist I — Global Submissions
Regulatory Affairs Specialist I — Global Submissions

BCforward • Laurel (MD)

On-site
USD 61,702
Regulatory Affairs Manager: Drive Compliance & Strategy
Regulatory Affairs Manager: Drive Compliance & Strategy

Course Advisor • United States

On-site
USD 90,000 - 130,000
Senior Regulatory Strategy & Submissions Lead
Senior Regulatory Strategy & Submissions Lead

Integrated Resources Inc. • Jersey City (NJ)

On-site
USD 70,000 - 90,000
Regulatory Submissions Lead — FDA & Global
Regulatory Submissions Lead — FDA & Global

Monte Rosa Therapeutics • Boston (MA)

On-site
USD 85,000 - 115,000
Regulatory Affairs Specialist
Regulatory Affairs Specialist

Indotronix Avani Group • Irvine (CA)

On-site
USD 65,000 - 90,000
Regulatory Program Manager — Global Submissions Lead
Regulatory Program Manager — Global Submissions Lead

Integrated Resources Inc. • Lower Gwynedd Township

On-site
USD 100,000 - 140,000
Referral bonus