Senior Regulatory Affairs Consultant – CMC Biologics

🔥 13 hours ago

🇺🇸 United States – Remote

⏰ Full Time

🟠 Senior

🚔 Compliance

🦅 H1B Visa Sponsor

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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

• Support regulatory leads in developing CMC regulatory strategies and contingency plans for biologic and small molecule drug substances, drug products, and drug-device combination products • Determine regulatory and scientific/technical requirements for CMC and GMP-related submissions and regulatory inquiries • Represent CMC regulatory affairs in project team meetings and provide regulatory guidance and perspective to cross-functional teams in conjunction with global regulatory leads • Prepare, coordinate, and review CMC and GMP-related documents for submission to regulatory authorities • Develop CMC regulatory strategies for developmental phase products from early development through marketing applications • Support post-approval changes for marketed products • Interact with manufacturing, quality, and partner organizations to address CMC-related issues and ensure alignment • Develop and maintain relationships with local and global functional units, manufacturing sites, contract manufacturers, and external partner companies • Support preparation for health authority CMC meetings and mock meetings • Assess and develop ideas to optimize CMC regulatory departmental processes and improve efficiencies • Support regulatory strategy and compliance for drug development across investigational, new, and marketed products • Collaborate with manufacturing, quality, and project management teams • Contribute to product development from early stages through post-approval

🎯 Requirements

• Bachelor's degree in Pharmaceutical Sciences, Chemistry, or Pharmacy (PharmD) • 7+ years of CMC experience in the pharmaceutical industry with a demonstrated history of successful regulatory filing documentation • Comprehensive knowledge of drug development processes, pharmaceutical technology, drug manufacturing processes, and GMP requirements • Knowledge of CMC regulatory requirements for biologics and small molecules during development and post-approval, including biologic upstream and downstream processes, analytical methods, and drug-device combination products • Comprehensive experience preparing CMC (Quality) sections for investigational and marketed product submissions (IND, NDA, DMF) for FDA and equivalent submissions for Europe and Canada • Comprehensive understanding of the global regulatory environment • Strong analytical, problem-solving, organizational, and negotiation skills • Strong collaborative, interpersonal, communication, and presentation skills • Demonstrated ability to work independently, manage multiple projects, and prioritize in a matrixed environment • Proficiency with Microsoft Office applications (Word, Excel, PowerPoint, Outlook) • Experience working in pharmaceutical development, regulatory affairs, or a highly regulated environment • Comfort working with regulatory information systems, document management platforms, and Microsoft Office applications

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