Regulatory Affairs Director *PC 954

Your Role

The Director, Regulatory Affairs with CMC focus manages regulatory CMC activities for Miltenyi Biomedicine’s cell therapy programs in the US, Canada, and other regions as applicable. This role partners with functional teams from Bioindustry and Biotec to develop and implement regulatory strategies that support clinical trials, health authority interactions, and product approvals. The Director provides strategic input on CMC requirements for advanced therapy products and supports regulatory submissions throughout the product lifecycle.

Essential Duties and Responsibilities

• Develop and implement CMC regulatory strategies to support clinical development, marketing applications, and post-approval lifecycle management for cell and gene therapy products.
• Provide strategic regulatory guidance to cross-functional teams to align CMC development with regulatory expectations and business objectives.
• Lead the preparation, authorship, and review of CMC sections for INDs, CTAs, BLAs, and MAAs, including amendments and responses to health authority queries.
• Collaborate closely with process development, analytical development, regulatory operations, and external consultants to ensure timely delivery of CMC milestones, data packages, and submission-ready documentation.
• Oversee and provide regulatory input on process changes, comparability assessments, validation activities, and technical justifications to support manufacturing operations and regulatory submissions.
• Participate in change control evaluations to ensure proposed changes remain within regulatory compliance and align with registered dossiers.
• Support BLA/MAA CMC preparation activities and ensure readiness for regulatory interactions and marketing authorization.
• Represent Regulatory CMC in meetings with global health authorities, including preparation of briefing packages and participation in formal meetings.
• Identify, assess, and communicate CMC regulatory risks across programs