Senior Director Regulatory Affairs Strategy Cell Therapy
Overview
Lead global regulatory vision for pioneering cell therapies and transform breakthrough science into patient options. Set competitive pathways to approval and labeling while reporting to the Executive Director. Shape strategy across cancer immune-mediated and rare diseases. Own end-to-end regulatory strategy for complex programs and influence global health authorities. Drive accelerated access through rigorous pace and clarity.
What You'll Do11
- 1Own the end-to-end global regulatory strategy for a high-complexity cell therapy program from current stage through BLA submission ensuring efficient route to approval with competitive labeling aligned to patient market and business needs
- 2Serve as global regulatory lead for multi-indication programs and regional lead where relevant integrating region-specific strategy and execution
- 3Lead strategy for agency meetings information requests and expedited pathway designations driving robust preparation securing clear outcomes de-risking pivotal milestones
- 4Direct global dossier and core prescribing information planning constructing target product labeling strategy and negotiation readiness
- 5Represent Regulatory Affairs on Global Product Teams shaping development and commercialization plans contributing to governance presentations aligning regulatory objectives with clinical CMC safety and commercial strategies
- 6Continuously assess emerging data against program aspirations presenting risks trade-offs and mitigations to senior leadership enabling data-driven decisions
- 7Oversee all regulatory deliverables and milestones including probability-of-success assessments and contingency planning protecting timelines and value
- 8Lead a Global Regulatory Strategy Team coaching mentoring and line-managing members to build capability and performance
- 9Build strong relationships with regulatory stakeholders partnering with country and regional teams to shape developing views and guidance
- 10Develop novel regulatory tools and technology promoting innovation advancing how we work and impact delivered
- 11Maintain accountability for product maintenance and compliance activities associated with marketed brands ensuring continued benefit to patients and compliance with evolving requirements
Requirements16
- 1Advanced degree in a science related field and seven to ten years of experience or equivalent knowledge and experience
- 2Demonstrated success in cell therapy regulatory strategy
- 3Deep understanding of global regulatory science integration with program strategy
- 4Long-standing experience of overall drug/biologic development processes and strategies for high profile complex or novel development programs
- 5Experience with product development in oncology autoimmune rare diseases neurology therapeutic areas
- 6Broad background of experience working in pharmaceutical business and prior experience in several regulatory affairs areas
- 7Proven experience leading regulatory and cross-functional teams and stakeholder management
- 8Ability to think strategically critically evaluate risks to regulatory activities
- 9Previous experience leading Health Authority interactions in major markets
- 10Excellent oral written and presentation skills strong organizational abilities
- 11Flexible proactive ability to manage multiple projects and adapt to changing business needs
- 12Successful leadership of at least one global regulatory approval including leading response team and labeling negotiations
- 13Experience with FDA advisory committee and/or EMA oral explanation
- 14Due diligence activities and business alliance environment experience
- 15Coaching or mentorship experience
- 16Contribution to non-project business initiatives at portfolio or cross functional level
Salary Insight
$218 - $327k per year
Location
Required Skills
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