Senior Regulatory Affairs Associate – CTA Senior Specialist

🔥 0 minutes ago

🇺🇸 United States – Remote

⏰ Full Time

🟠 Senior

🚔 Compliance

🦅 H1B Visa Sponsor

This company has sponsored H1B visas in the past.

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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 • Implement global CTA strategy • Ensure quality and compliance with country-specific requirements across regulatory submissions • 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

🎯 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 • Experience coordinating cross-functional teams and managing vendor relationships • Experience in clinical research, healthcare, or a regulated environment • Strong communication, organization, and problem-solving skills • Advanced degree in Life Science, Regulatory Affairs, or related field preferred • Familiarity with regulatory submission tracking systems and electronic document management tools preferred • Knowledge of additional regulatory pathways beyond EU requirements preferred

🏖️ 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 • Additional benefit offerings in accordance with applicable plans • Potential eligibility for additional incentives, bonuses, or other compensation programs