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Executive Director – Regulatory Affairs Strategy, Cell Therapy
Job in
California, Moniteau County, Missouri, 65018, USA
Listed on 2026-09-16
Listing for:
Jobtailor
Full Time
position Listed on 2026-09-16
Job specializations:
-
Pharmaceutical
Regulatory Compliance Specialist
Job Description & How to Apply Below
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
- 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
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
Skills:
- Regulatory Strategy Development
- Dossier Construction
- Health Authority Interactions
- Oncology Product Development
- Autoimmune Disease Knowledge
- Rare Disease Expertise
- Neurology Product Development
- Excellent Oral Communication
- Strong Written Communication
- Presentation Skills
- Organizational Skills
Qualifications:
- Advanced Degree in Science‑Related Field
- Regulatory Affairs
- Global Product Teams
- Strategic Planning
- Cross‑Functional Stakeholders
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