Regulatory Affairs Consultant, CMC – Biologics

🔥 48 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

• Support Regulatory Affairs leads in developing CMC regulatory strategies and contingency plans for biologic and small molecule drug substances, drug products, and drug-device combination products • Support CMC regulatory strategies for development-phase products from early development through marketing applications and post-approval changes • Determine regulatory, scientific, and technical requirements for CMC and GMP-related submissions and inquiries • Prepare, coordinate, and review CMC and GMP-related documents for submission to regulatory authorities • Represent CMC Regulatory Affairs in project team meetings and provide regulatory guidance to cross-functional teams • Support preparation for health authority CMC meetings, including mock meetings and meeting planning • Support monthly CMC GRT meetings with global cross-functional teams • Interact with manufacturing and quality groups, partner organizations, and other stakeholders on CMC issues • Develop and maintain collaborative relationships with CMC Regulatory Affairs, manufacturing sites, Quality, Technical Operations, affiliates, external partners, contract manufacturers, packagers, and suppliers • Prepare departmental job procedures • Assess and develop innovative ideas to optimize CMC Regulatory Affairs departmental processes, improve efficiencies, and address current and future challenges • Provide CMC regulatory strategy input and expertise for investigational, new, and marketed biologic and small molecule drug products • Support compliance with global regulatory requirements and guidance, with primary responsibility for the US, EU, and Canada

🎯 Requirements

• Bachelor's degree in Pharmaceutical Sciences or Chemistry, or a Pharm.D. • 4-6 years of CMC experience in the pharmaceutical industry, with a history of successfully preparing regulatory filing documentation • Comprehensive knowledge of the drug development process, pharmaceutical technology, drug manufacturing processes, GMP, and related issues • Knowledge of CMC regulatory requirements for biologics and small molecules during development and post-approval, including biologic upstream and downstream processes, analytical methods, and drug-device combination products • Comprehensive knowledge and experience preparing CMC (Quality) sections for investigational and marketed product submissions (IND, NDA, DMF) for the FDA and equivalent submissions for Europe and Canada • Comprehensive understanding of the global regulatory environment • Demonstrated experience with Microsoft Word, Excel, PowerPoint, and Outlook • Strong analytical, problem-solving, organizational, and negotiation skills • Strengths in proactive strategic thinking, analytical problem solving, and negotiation • Experience working in the pharmaceutical industry within a regulated environment • Strong collaborative, communication, and presentation skills, with the ability to lead meetings and work effectively in a matrixed environment and across cultural lines • Ability to prepare high-quality technical documents and submissions using internal systems • Ability to independently manage and prioritize a multi-project workload • Proficiency with document management and regulatory information systems, Trackwise Digital, and TRS Viewer • Preferred: Master's or Ph.D. degree, preferably in Pharmaceutics, Biochemistry, Molecular Biology, Biotechnology, or Biology • Preferred: Regulatory Affairs Certification (RAC) • Preferred: Experience in CPP application filing through eCATS and 510(j)(3) reporting through nextGen portals

🏖️ 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

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