CMC Regulatory Affairs Senior Consultant – Small Molecules

October 8

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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

• Provide regulatory strategy input for small molecules (previous experience with biologics and/or drug-device combination products are a plus) • Support regulatory leads in developing contingency plans for CMC-related scenarios • Represent CMC Regulatory Affairs in cross-functional project meetings and provide regulatory guidance in collaboration with global regulatory leads • Prepare, coordinate, and review CMC and GMP-related documents for regulatory submissions • Develop CMC strategies for products across all phases—from early development to marketing applications and post-approval changes • Partner with manufacturing, quality, and external organizations to address CMC-related issues • Maintain collaborative relationships with internal stakeholders, affiliates, contract manufacturers, packagers, and suppliers • Support planning and execution of Health Authority meetings, including mock sessions • Identify and implement process improvements to enhance regulatory efficiency and readiness • Participate in monthly CMC Global Regulatory Team meetings to align strategies across functions • Utilize regulatory systems and tools including CREDO, Trackwise Digital, and TRS Viewer

🎯 Requirements

• 4–6 years of CMC regulatory experience in the pharmaceutical industry for a Consultant level role, 7+ years for a Senior Consultant • Proven success in preparing regulatory documentation for FDA, EMA, and Health Canada (IND, NDA, DMF) • In-depth understanding of drug development, manufacturing processes, GMP, and regulatory frameworks for small molecules. Previous experience with biologics or combination device products are a plus! • Bachelor’s degree in Pharmaceutical Sciences, Chemistry, or related field • Advanced degrees (Pharm.D., M.S., Ph.D.) in Pharmaceutics, Biochemistry, Molecular Biology, Biotechnology, or Biology preferred • RAC certification is a plus

🏖️ Benefits

• Health insurance • Flexible work arrangements • Professional development opportunities