Remote Senior Regulatory Intelligence Lead

Parexel; Oregon; Hybrid; USD 110,000 - 150,000; Full time

Benefits offered by this job

Health, Vision & Dental Insurance

Tuition Reimbursement

Vacation/Holiday/Sick Time

Flexible Spending & Health Savings

401(k) with Company match

Pet Insurance

Job summary

Parexel is seeking a Senior Regulatory Affairs Associate, Regulatory Intelligence, to join our team remotely. You will monitor global regulations, assess impact, and support compliance across medicines, biologics, and devices.

Ideal candidates bring 2+ years in regulatory intelligence, strong collaboration, and proficiency with AI-enabled platforms and MS Office. You will contribute to audits, taxonomy management, and stakeholder communications while advancing global regulatory strategies.

Qualifications

• Bachelor’s degree in a scientific or technical field.
• 2+ years of work experience in regulatory intelligence.
• Strong written and verbal communication skills.

Responsibilities

• Monitor the regulatory intelligence platform and sources to identify regulations and guidelines.
• Distribute approved content to stakeholders for impact assessment and gap analysis.
• Collaborate with subject matter experts to assess regulatory changes on products and pipelines.
• Maintain communication with stakeholders to track impact assessments and gaps.
• Analyze compliance metrics and follow up with actions to minimize risk.
• Use AI-enabled tools to tag and summarize GxP content and maintain taxonomy.
• Participate in audits and inspections with evidence of regulatory tracking.

Skills

Project planning

Cross-functional collaboration

Effective communication

Attention to detail

Microsoft Office

Education

Bachelor's degree in scientific or technical discipline

Tools

AI-enabled regulatory intelligence platform

Document management systems

Microsoft Office

Job description

Parexel is seeking a Senior Regulatory Affairs Associate, Regulatory Intelligence, to join our team remotely. You will monitor global regulations, assess impact, and support compliance across medicines, biologics, and devices.

Ideal candidates bring 2+ years in regulatory intelligence, strong collaboration, and proficiency with AI-enabled platforms and MS Office. You will contribute to audits, taxonomy management, and stakeholder communications while advancing global regulatory strategies.