Senior Regulatory Intelligence Analyst (Remote)

Parexel; United States; Remote; USD 90,000 - 140,000; Full time

Benefits offered by this job

Health, Vision & Dental Insurance

Tuition Reimbursement

Vacation/Holiday/Sick Time

Flexible Spending & Health Savings

Work/Life Balance

401(k) with Company match

Pet Insurance

Job summary

Parexel in the United States is seeking a Senior Regulatory Affairs Associate, Regulatory Intelligence to join our team remotely. You will monitor global regulations, guide impact assessments, and support compliance across GxP areas, collaborating with SMEs and IT to optimize regulatory change management.

The role emphasizes timely identification of regulatory changes, data-driven reporting, and audits support.

Qualifications

• 2+ years of work in regulatory intelligence.
• Bachelor's degree in a scientific or technical discipline.
• Experience analyzing and reporting compliance metrics.
• Solid knowledge of drug, biologic, and device development processes and FDA/EMA/ICH guidelines.
• Ability to plan, direct, organize, and coordinate projects.
• Excellent interpersonal and written/verbal communication skills.
• Critical thinking and problem-solving abilities.
• Results-driven, team-oriented approach.
• Proficient with Microsoft Office programs (Word, Excel, PowerPoint, Outlook).

Responsibilities

• Monitor the regulatory intelligence platform and sources to identify new regulations, guidelines, and policies globally.
• Distribute approved content for impact assessment and update stakeholder lists.
• Collaborate with SMEs to assess regulatory changes on products, pipelines, and operations.
• Maintain communication with stakeholders to track implementation of impact assessments and gap analyses.
• Analyze and report compliance metrics and follow up with actions to minimize risks.
• Use AI-enabled regulatory intelligence platform to tag and summarize content and update taxonomy.
• Assist in audits and inspections by providing evidence of tracking and analysis.
• Familiarize with GSOPs/WPs in the document management system.
• Coordinate with IT and platform vendors to triage issues and access requests.
• Demonstrate understanding of priorities from industry associations (PhRMA, EFPIA, JPMA).
• Stay current with regulatory trends and technologies to improve compliance activities.

Skills

Project planning

Coordination

Critical thinking

Communication

Regulatory intelligence

Microsoft Office

Team collaboration

Education

BSc/BA in science/tech

Tools

Microsoft Office

Job description

Parexel in the United States is seeking a Senior Regulatory Affairs Associate, Regulatory Intelligence to join our team remotely. You will monitor global regulations, guide impact assessments, and support compliance across GxP areas, collaborating with SMEs and IT to optimize regulatory change management.

The role emphasizes timely identification of regulatory changes, data-driven reporting, and audits support.