Regulatory Operations Coordinator

Career Guide

A Regulatory Operations Coordinator supports teams that prepare and maintain regulatory documents and submissions. The role focuses on keeping records accurate, tracking deadlines, coordinating reviews, and ensuring required materials are complete and delivered on time.

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Key Responsibilities

Maintain regulatory document repositories and version history
Coordinate document review cycles and capture approvals
Track submission timelines, milestones, and action items
Prepare submission-ready files and perform quality checks
Support publishing and delivery of submissions to regulators
Log incoming requests, questions, and agency communications
Maintain product and submission trackers for internal visibility
Coordinate meetings, agendas, and status updates for regulatory projects
Support audit readiness by keeping records organized and retrievable
Collaborate with quality, clinical, and product teams to collect required content

Top Skills for Success

Attention to Detail

Time Management

Written Communication

Stakeholder Coordination

Document Control

Version Management

Submission Tracking

Quality Review

Regulatory Submissions

Records Management

Career Progression

Can Lead To

Regulatory Operations Specialist

Regulatory Operations Associate

Regulatory Submissions Specialist

Regulatory Coordinator

Quality Documentation Specialist

Transition Opportunities

Regulatory Affairs Associate

Regulatory Project Manager

Quality Assurance Specialist

Clinical Trial Administrator

Compliance Analyst

Common Skill Gaps

Often Missing Skills

Regulatory Publishing ToolsSubmission Format StandardsMetadata ManagementProcess ImprovementBasic Project Management

Development SuggestionsBuild strength in submission workflows by practicing controlled document processes, learning common submission standards, and using a structured tracker for deadlines and approvals. Seek opportunities to own a small submission component end to end and request feedback on quality checks.

Salary & Demand

Median Salary Range

Entry LevelUSD 55,000 to 70,000

Mid LevelUSD 70,000 to 90,000

Senior LevelUSD 90,000 to 115,000

Growth Trend

Steady demand, especially in life sciences and medical technology, driven by ongoing product updates, expanded compliance expectations, and higher documentation volumes.

Companies Hiring

Major Employers

PfizerJohnson and JohnsonMerckRocheNovartisAstraZenecaGSKSanofiAbbVieMedtronicAbbottThermo Fisher ScientificIQVIALabcorpParexel

Industry Sectors

PharmaceuticalsBiotechnologyMedical DevicesContract Research OrganizationsConsumer HealthDiagnostics

Recommended Next Steps

Create a portfolio example of a document tracker and review workflow you have managed

Learn one regulatory publishing or document management system used in your target industry

Practice quality checks using a repeatable checklist for formatting, completeness, and references

Ask to support a submission timeline so you can demonstrate deadline and dependency management

Update your resume with measurable coordination results such as on time delivery and error reduction