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
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