Regulatory Affairs Consultant – CMC, US/EU – Mature Biological Products

🔥 20 hours ago

🇨🇦 Canada – Remote

⏰ Full Time

🟡 Mid-level

🟠 Senior

🚔 Compliance

👻 Ghost score 10%

What it means: how likely this posting is sitting open without active hiring.How to read it: 60% or higher means we think this is a ghost. Lower scores are less of a worry.How we score it: age, reposts, open roles vs team size, how fast jobs close, and whether pay is listed.Fine print: an estimate from public data, not a judgment of the company. Real jobs can score high, so treat it as a hint, not a fact.

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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 CMC regulatory strategies for global product lifecycle activities, including variations and post-approval changes • Author and review high-quality CMC documentation for Modules 1-3 for global submissions • Support and lead global submissions in the US, EU, and beyond from planning through execution • Perform CMC dossier gap analyses and provide clear, strategic recommendations • Partner cross-functionally with Regulatory, Quality, Manufacturing, and client stakeholders • Act as a key contributor within a dedicated client team and build strong, trusted relationships • Ensure submissions meet global regulatory expectations with precision and excellence • Influence CMC regulatory strategy and regulatory outcomes as a trusted advisor • Contribute to lifecycle management activities and long-term client partnerships

🎯 Requirements

• 3+ years of experience in CMC Regulatory Affairs or CMC Strategy for a Senior Associate role • 5+ years of experience in CMC Regulatory Affairs or CMC Strategy for a Regulatory Affairs Consultant role • Hands-on experience with commercial biologicals and/or vaccines • Strong knowledge of global regulatory requirements, including FDA, EMA, and international markets • Proven experience in global submission management • Expertise in authoring and reviewing CMC Modules 1-3 to support variations • Experience performing CMC dossier gap analyses • Strengths in CMC regulatory strategy, CMC Modules 1-3 authoring and review, and dossier gap analysis • Experience in CMC Regulatory Affairs or CMC Strategy within a regulated biopharmaceutical environment • Ability to collaborate across teams, manage stakeholders, and communicate clearly • Patient-focused mindset, commitment to quality and integrity, and strong attention to detail • Comfort working with global submission processes and regulatory documentation standards • Experience with Veeva Vault (RIM/eCTD systems) preferred • Candidates must be located in Canada; flexibility to work Eastern Time hours is required for candidates outside Canada's eastern time zone

🏖️ Benefits

• Comprehensive benefits package for eligible employees • Competitive salaries based on position and level offered, skills, education, training, experience, professional achievements, and location • Some roles may be eligible for additional incentives, bonuses, or other compensation programs • Flexibility, growth, and space to do their best work • Continuous learning opportunities • Global exposure across US, EU, and international regulatory landscapes