CMC Regulatory Affairs Senior Consultant – Small Molecules
Job 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 Apply tot his job