Senior Regulatory Affairs Associate – Regulatory Intelligence

🔥 0 minutes ago

🌐 United States, Canada – Remote

🇺🇸 United States – Remote 🇨🇦 Canada – Remote

⏰ Full Time

🟠 Senior

🚔 Compliance

🦅 H1B Visa Sponsor

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Parexel

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 1983

💼 Consulting

🏥 Healthcare

📦 Logistics

💰 Venture Round on 1990-01

Consulting • Healthcare • Logistics

Parexel is one of the world's largest clinical research organizations (CROs), providing comprehensive services for the clinical development process from Phase I to IV. The company specializes in portfolio management, clinical trial management, regulatory strategy, market access, and lifecycle management for biopharmaceuticals. Parexel aims to speed life-changing medicines to market by leveraging its clinical, regulatory, and therapeutic expertise. With a global team of over 21,000 professionals, Parexel works to integrate patient insights and innovative trial designs to develop treatments across therapeutic areas such as oncology, neuroscience, rare diseases, and more. It focuses on delivering patient-centric and efficient clinical trials.

📋 Description

• Monitor the regulatory intelligence platform and other information sources to identify and track new and evolving regulations, guidelines, standards, and policies from global regulatory bodies • Review regulatory content for relevance, distribute approved content to key stakeholders for impact assessment and gap analysis, and update stakeholder distribution lists • Collaborate with subject matter experts to assess implications of regulatory changes on products, development pipelines, and business operations • Track implementation of impact assessments and gap analyses with key stakeholders • Analyze and report impact assessment compliance metrics and follow up on risk-mitigation actions • Use the AI-enabled regulatory intelligence platform and dashboards to identify, tag, and summarize GxP-related content and update AI taxonomy terms • Participate in audits and inspections by supplying regulatory intelligence tracking and impact assessment evidence • Maintain familiarity with global standard operating procedures and working procedures in the document management system • Coordinate with Information Technology, Regulatory Technology, and the platform vendor on technical problems, access requests, and distribution issues • Stay current with regulatory intelligence trends and technologies and share learnings to improve compliance activities

🎯 Requirements

• Minimum of 2 years of work experience in regulatory intelligence • Bachelor's degree in a scientific or technical discipline • Previous experience analyzing and reporting compliance metrics • Solid working knowledge of drug, biologic, and device development processes, and of the laws, regulations, and guidelines from the FDA, EMA, PMDA, and ICH • Ability to plan, direct, organize, and coordinate projects • Excellent interpersonal skills, with strong written and verbal communication • Critical thinking and problem-solving skills • Results-driven, team-oriented collaborative approach • Strong demonstrated experience with Microsoft Office programs (Word, Excel, PowerPoint, Outlook) • Experience working in clinical research, healthcare, or a regulated environment • Comfort working with an AI-enabled regulatory intelligence platform, document management systems, and Microsoft Office • Preferred: Minimum of 2 years of regulatory affairs experience • Preferred: Previous interactions with the FDA or other health authorities • Preferred: Previous experience with pharmacovigilance or regulatory work in pharmacovigilance • Preferred: Previous experience developing newsletters

🏖️ Benefits

• Health, Vision & Dental Insurance • Tuition Reimbursement • Vacation/Holiday/Sick Time • Flexible Spending & Health Savings Accounts • Work/Life Balance • 401(k) with Company match • Pet Insurance • Some roles may also be eligible for additional incentives, bonuses, or other compensation programs