Director, Regulatory Affairs

Responsibilities Own the end-to-end global regulatory strategy for a cell therapy product Represent Regulatory Affairs on Global Product Teams Lead strategy for major health authority interactions Maintain a deep and current working knowledge of relevant disease areas and regulatory policy Lead one or more Global Regulatory Strategy Teams Ensure strong strategic planning and construction of the global dossier Partner with marketing companies and cross‑functional stakeholders Requirements An advanced degree in a science‑related field At least ten or more years of experience and/or appropriate knowledge/experience Demonstrated extensive success in cell therapy regulatory strategy Deep understanding of global regulatory science Long‑standing experience of drug/biologic development processes and strategies for high profile, highly complex programs Experience with product development in oncology, autoimmune, rare diseases, neurology Proven experience leading regulatory and cross‑functional teams Excellent oral, written, and presentation skills Strong organizational skills Core Competencies Expertise in global regulatory strategy for cell therapy products, with a strong background in drug and biologic development processes. Proven ability to lead cross‑functional teams and engage with health authorities while maintaining a deep understanding of relevant disease areas and regulatory policies. Highest‑signal resume keywords Cell Therapy Regulatory Strategy Global Regulatory Science Drug/Biologic Development Processes Leadership of Regulatory Teams Cross‑Functional Collaboration ATS Optimization Keywords Hard Skills: Regulatory Strategy Development Dossier Construction Health Authority Interactions Oncology Product Development Autoimmune Disease Knowledge Rare Disease Expertise Neurology Product Development Soft Skills: Excellent Oral Communication Strong Written Communication Presentation Skills Organizational Skills Certifications & Qualifications: Advanced Degree in Science‑Related Field Industry Keywords: Regulatory Affairs Global Product Teams Strategic Planning Cross‑Functional Stakeholders #J-18808-Ljbffr