Regulatory Affairs Consultant – CMC Biologics, Plasma Products

🔥 0 minutes ago

🇺🇸 United States – Remote

⏰ Full Time

🟡 Mid-level

🟠 Senior

🚔 Compliance

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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

• Develop submission strategies and plans for post-approval CMC activities such as variations, renewals, market expansions, and annual reports • Assess change controls and provide regulatory assessments of quality changes in production and quality control processes • Review study reports and quality documentation from manufacturing and quality control departments to ensure compliance with regulatory requirements • Coordinate submission preparation with manufacturing, supply chain, quality control, quality assurance, and other regulatory departments • Write and review submission content related to variations and responses to health authority questions • Manage projects within Regulatory Information Management systems, ensuring the maintenance and accuracy of worldwide submissions • Identify, escalate, and mitigate risks associated with regulatory procedures and activities across global markets • Support post-approval regulatory activities and contribute to regulatory operations from submission planning through approval and market expansion • Collaborate with cross-functional teams including manufacturing, quality, and supply chain partners

🎯 Requirements

• Bachelor’s in Chemistry or a related Life Sciences field of study • 5+ years of experience in regulatory affairs, particularly in technical/CMC/quality regulatory roles within the pharmaceutical industry • Strong understanding of CMC and post-approval regulatory requirements for global markets (US, EU, CA, CH, AU, CN, BR) • Experience in writing CMC (technical) sections of regulatory documents such as registration files or variations • Previous biologics regulatory CMC experience • Expertise in CMC regulatory strategy, post-approval regulatory processes, and quality/technical documentation • Experience working in regulatory affairs, pharmaceutical quality, or a highly regulated environment • Ability to collaborate across teams and communicate clearly with internal stakeholders and regulatory authorities • Quality-focused mindset and strong attention to detail in regulatory documentation and compliance • Comfort working with regulatory information management systems, Word, PowerPoint, and Excel • Strong communication, organization, and problem-solving skills

🏖️ 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 • Paid time off • Life insurance • Flexible work arrangements • Potential eligibility for additional incentives, bonuses, or other compensation programs