Senior Regulatory Affairs Consultant, CMC – Post-Approval Vaccines

🔥 3 minutes ago

🇺🇸 United States – Remote

⏰ Full Time

🟠 Senior

🚔 Compliance

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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 strategic direction and oversight for CMC aspects of late-stage and marketed products • Develop and oversee CMC strategies for product development, registration, and lifecycle management • Lead complex regulatory submissions, including INDs, IMPDs, BLAs, MAAs, post-approval variations and supplements, and responses to health authority questions • Author and review high-level regulatory submissions and ensure compliance with health authority guidelines and regulations • Lead submission preparation meetings with coordinated cross-functional input • Lead regulatory CMC discussions and interactions with health authorities • Represent the company in high-level meetings with regulatory agencies and maintain relationships with regulatory stakeholders • Develop strategies for complex regulatory questions and manage sensitive regulatory correspondence • Oversee regulatory assessments of manufacturing changes and establish data requirements for related submissions • Represent Regulatory CMC at project team meetings and governance committees • Collaborate with R&D, Manufacturing, Quality Assurance, Clinical Development, external partners, and regulatory authorities • Provide senior management updates on project status, risks, and milestones • Mentor and develop team members in Regulatory CMC practices and strategic thinking • Monitor evolving CMC regulations and industry best practices and develop innovative regulatory strategies

🎯 Requirements

• Advanced degree in Pharmaceutical Sciences, Chemistry, Chemical Engineering, or a related field • Minimum of 10+ years of experience in Regulatory Affairs, with a strong focus on CMC for late-stage and marketed products • Extensive knowledge of global CMC regulatory requirements, submission processes, and health authority expectations • Deep understanding of pharmaceutical development, manufacturing processes, and quality systems • Proven track record of successful regulatory submissions and positive health authority interactions • Strong analytical, communication, organization, and problem-solving skills • Excellent project management skills and ability to influence and lead at senior levels • Experience working in a regulated pharmaceutical environment, focused on CMC for late-stage and marketed products • Ability to collaborate across senior leadership teams, influence cross-functional stakeholders, and communicate clearly at every level • Comfort working with global regulatory submission processes, health authority expectations, and quality systems

🏖️ 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 • Some roles may also be eligible for additional incentives, bonuses, or other compensation programs

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