Senior Regulatory Affairs Associate – CTA Senior Specialist

🔥 5 minutes ago

🇨🇦 Canada – Remote

⏰ Full Time

🟠 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

• Provide operational and regulatory support for CTA submissions and maintenance activities • Prepare and coordinate global CTA and amendment documentation • Manage dossier development and ensure quality and completeness • Manage or facilitate submissions to health authorities or via local personnel • Serve as the primary point of contact for regulatory interactions • Liaise with and oversee CROs for submissions and query management • Ensure timely and accurate responses to regulatory inquiries • Implement global CTA strategy • Ensure quality and compliance with country-specific requirements • Maintain tracking and archiving of regulatory submissions • Communicate EU regulatory requirements and updates to cross-functional teams • Contribute to process improvements in regulatory submission management • Collaborate with cross-functional teams and follow industry-standard processes from planning through closeout

🎯 Requirements

• Bachelor's degree in Life Science or equivalent experience • 6+ years in pharmaceutical industry with 5+ years in Regulatory Affairs • Strong knowledge of EU drug development, CTR, and CTIS regulatory frameworks • Demonstrated experience with CTA submission processes and regulatory compliance • Proven leadership in EU CTA documentation and submissions • Strong knowledge of EU drug development, CTR, and CTIS workflows across multiple jurisdictions • Project management and leadership skills • Ability to coordinate cross-functional teams and manage vendor relationships • Excellent communication, organization, collaboration, and problem-solving skills • Experience in clinical research, healthcare, or a regulated environment • Strong attention to detail and quality mindset • Familiarity with regulatory submission tracking systems and electronic document management tools • Knowledge of additional regulatory pathways beyond EU requirements is preferred • Ability to work ET hours; eastern or central time zone of Canada highly preferred

🏖️ Benefits

• Competitive salaries based on position, level, skills, education, training, experience, professional achievements, and location • Some roles may be eligible for additional incentives, bonuses, or other compensation programs • Flexibility • Growth opportunities • Space to do your best work • Continuous learning opportunities