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Regulatory Documentation Manager - Job Opportunity at Advarra, Inc.

Remote, US
Full-time
Senior
Posted: March 15, 2025
Remote
USD 86,900 - 146,900 per year

Benefits

Comprehensive health insurance with competitive coverage
Paid holidays with flexible scheduling
Variable bonus potential indicating performance-based culture
Remote work flexibility demonstrating modern workplace practices

Key Responsibilities

Lead development and management of regulatory documentation including policies, procedures, and technical reports
Drive cross-functional collaboration with Research Services teams to ensure regulatory compliance
Create and maintain training modules for Advarra University
Conduct industry research and competitive analysis to inform documentation strategy
Manage relationships with Review Services business unit stakeholders

Requirements

Education

Bachelor's degree from an accredited college or university required

Experience

Minimum of ten (10) years in clinical research or similar regulatory field

Required Skills

Working knowledge of regulatory standards (FDA, OHRP, Health Canada) Strong writing and editing skills Project management capabilities Microsoft Office proficiency Organizational and time management skills Interpersonal communication skills Independent work capability
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Sauge AI Market Intelligence

Industry Trends

Clinical research regulatory complexity is increasing with the rise of decentralized trials and digital health technologies, creating higher demand for documentation expertise Integration of AI and automation in clinical trials is driving need for updated regulatory frameworks and documentation processes Growing focus on patient-centricity in clinical research is reshaping documentation requirements and communication strategies

Salary Evaluation

The offered salary range of USD 86,900 - 146,900 aligns with market expectations for senior regulatory roles, reflecting the specialized expertise required. The wide range suggests room for negotiation based on experience and capabilities.

Role Significance

Typically operates within a team of 5-8 regulatory professionals, collaborating with multiple cross-functional teams of 15-20 members
Senior individual contributor role with significant influence on organizational compliance and operational efficiency. Position requires both strategic thinking and hands-on execution.

Key Projects

Development of comprehensive regulatory documentation systems Creation of training programs for regulatory compliance Strategic documentation initiatives for new research methodologies Cross-functional process improvement projects

Success Factors

Deep understanding of evolving regulatory landscape in clinical research Ability to translate complex requirements into clear documentation Strong stakeholder management skills across multiple organizational levels Balance between strategic thinking and tactical execution

Market Demand

High demand position due to increasing regulatory complexity in clinical research and the expanding role of technology in trials. The field shows steady growth with limited qualified candidates.

Important Skills

Critical Skills

Regulatory knowledge spanning multiple agencies and frameworks Technical writing expertise for complex documentation Project management capabilities for cross-functional initiatives Stakeholder management across organizational levels

Beneficial Skills

Experience with electronic regulatory systems Knowledge of emerging clinical research technologies Change management expertise Training development capabilities

Unique Aspects

Integration of regulatory expertise with technology solutions
Focus on both traditional and innovative research methodologies
Strong emphasis on patient-centric approach in regulatory documentation
Combination of strategic and operational responsibilities

Career Growth

2-4 years in role typically required before advancement to director-level positions, depending on performance and organizational growth

Potential Next Roles

Director of Regulatory Affairs Head of Compliance Senior Manager of Clinical Operations Regulatory Strategy Lead

Company Overview

Advarra, Inc.

Advarra is a leading provider of regulatory review services and technology solutions in clinical research, positioning itself at the intersection of compliance and innovation

Market leader in IRB services with strong technology integration, competing with major CROs and specialized regulatory service providers
Strong presence in North American markets with growing international influence
Values-driven organization emphasizing ethical practices, quality focus, and collaborative approach. Remote-friendly culture indicates modern workplace practices.
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