Senior Regulatory Affairs Associate, CMC

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11 hours ago

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Parexel

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Healthcare Insurance • Biotechnology • Pharmaceuticals

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.

10,000+ employees

Founded 1983

⚕️ Healthcare Insurance

🧬 Biotechnology

💊 Pharmaceuticals

💰 Venture Round on 1990-01

📋 Description

• Develop comprehensive CMC strategies for early-stage programs and marketed products • Author and review regulatory submissions, including: • Investigational New Drug (IND) applications • Investigational Medicinal Product Dossiers (IMPDs) • Post-approval variations/supplements • Annual reports • Responses to health authority questions • Ensure all submissions conform to relevant health authority guidelines and regulations • Lead submission preparation meetings and coordinate cross-functional input • Perform regulatory assessments of manufacturing changes • Establish data requirements for regulatory submissions related to manufacturing changes • Provide expert guidance on CMC-related regulatory implications of proposed changes • Represent Regulatory CMC at project team meetings • Address reviewer comments and manage regulatory correspondence • Provide regular updates to Management on project status and key milestones • Mentor junior team members in Regulatory CMC practices • Work closely with various departments, including R&D, Manufacturing, Quality Assurance, and Clinical Development • Facilitate effective communication between internal teams and regulatory authorities • Provide CMC regulatory expertise to support business decisions and product development strategies • Stay current with evolving CMC regulations, guidelines, and industry best practices • Contribute to the development and implementation of internal CMC regulatory policies and procedures • Participate in relevant industry groups and regulatory authority meetings as needed

🎯 Requirements

• Advanced degree in Pharmaceutical Sciences, Chemistry, Chemical Engineering, or a related field (Ph.D. preferred) • Minimum of 8+ years of experience in Regulatory Affairs, with a strong focus on CMC • Extensive knowledge of global CMC regulatory requirements and submission processes • Proven track record of successful regulatory submissions and interactions with health authorities • Strong understanding of pharmaceutical development, manufacturing processes, and quality systems • Experience with both small molecules and biologics is highly desirable • Excellent project management skills with the ability to manage multiple projects simultaneously • Strong analytical and problem-solving skills • Outstanding written and verbal communication skills

🏖️ Benefits

• Health insurance • Retirement plans • Paid time off • Flexible work arrangements • Professional development