CMC Regulatory Affairs Senior / Consultant - Small Molecules

Cmc Regulatory Affairs Senior / Consultant

Exciting opportunity for an experienced and highly motivated professional to join our global regulatory affairs team. This role is critical to ensure our client's investigational, new, and marketed small molecule products are developed and maintained in compliance with global regulatory requirements. The primary regions of responsibility include the United States, European Union, and Canada, with a focus on facilitating timely approvals and supporting continued market access.

Key Responsibilities

• Strategic Cmc Leadership
• 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
• Submission & Documentation Excellence
• Prepare, coordinate, and review Cmc and Gmp-related documents for regulatory submissions
• Develop Cmc strategies for products across all phasesfrom early development to marketing applications and post-approval changes
• Cross-Functional Collaboration
• 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
• Process Optimization & Innovation
• 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
• Regulatory Systems & Reporting
• Experience with CPP application filing via eCATS and 510(j)(3) reporting through nextGen portals is a plus
• Ensure audit readiness and version control through meticulous documentation and system management

Qualifications

Given the client's location, preference will be given to candidates residing in the Eastern Time Zone. However, exceptional individuals based on other time zones will also be considered, provided they can accommodate the scheduling requirements of global meetings and calls as needed.