Senior Regulatory Affairs Consultant – Post Approval CMC Authoring, Vaccines or Biologics

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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

• Lead and contribute to global CMC regulatory strategies for commercial biologics and vaccine products • Support and drive post-approval regulatory activities, including variations, supplements, manufacturing changes, CMC changes, lifecycle maintenance, and health authority commitments • Author and review CMC documentation in Modules 1–3 for global submissions • Perform CMC dossier gap analyses and provide strategic recommendations • Lead and support global submissions from planning through execution • Partner cross-functionally with Regulatory Affairs, Quality, Manufacturing, Supply Chain, Technical Operations, and client stakeholders • Assess regulatory impact of product, process, manufacturing, analytical, and control strategy changes • Contribute within a dedicated client team and build trusted relationships • Ensure submissions meet global regulatory expectations with precision, quality, and compliance

🎯 Requirements

• 5+ years of experience in CMC Regulatory Affairs or CMC Strategy for a Regulatory Affairs Consultant role; 7+ years for a Senior Regulatory Affairs Consultant role • Demonstrated post-approval CMC regulatory experience supporting commercial biologics and/or vaccines • Hands-on experience managing lifecycle maintenance activities for approved biologic and/or vaccine products • Experience with post-approval supplements, variations, manufacturing changes, process changes, analytical method updates, site transfers, specification changes, health authority commitments, or labeling-related CMC changes • Strong knowledge of global regulatory requirements, including FDA, EMA, and international markets • Proven experience supporting global submission strategy and execution • Expertise authoring and reviewing CMC Modules • Experience performing CMC dossier assessments and gap analyses • Strong communication, collaboration, and stakeholder management skills • Ability to work directly with clients and cross-functional teams in a highly matrixed environment • Preferred: experience supporting clinical development and commercial lifecycle management activities • Preferred: experience with vaccines, biologics, monoclonal antibodies, recombinant proteins, gene therapies, or other advanced biologic modalities • Preferred: experience with Veeva Vault RIM, eCTD publishing, and regulatory information management systems • Preferred: advanced scientific degree (MS, PhD, PharmD, or equivalent)

🏖️ Benefits

• Dedicated client partnership and strategic partnership work • Meaningful work contributing to innovative biologics and vaccines that improve patient lives globally • Global exposure across US, EU, and international regulatory landscapes • Growth and influence through expanding expertise in biologics, vaccines, and post-approval CMC strategy