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In this role you will set the global regulatory direction for first-in-class cell therapies, translating science into timely approvals and impactful labels. You will lead strategy across discovery to commercialization, shaping engagement with health authorities and lifecycle management. As a senior leader, you’ll build capability, coach regulatory talent, and influence policy to sustain a competitive edge for the pipeline.
You’ll work with cross-functional teams to accelerate submissions and bring therapies to patients with unmet needs. This position offers an opportunity to influence integral strategy and drive meaningful patient impact.
Compensaciones / Beneficios
- Own end-to-end global regulatory strategy for a high-complexity cell therapy program through BLA submission and lifecycle management
- Represent Regulatory Affairs on Global Product Teams and guide development plans and risk management
- Lead health authority engagement, response strategies, and labeling negotiations to secure timely approvals
- Maintain external insight on regulatory science and policy to sustain competitive advantage
- Lead one or more Global Regulatory Strategy teams, coaching and developing senior regulatory talent
- Provide executive assessments of data and risks to inform senior leadership decisions
- Ensure delivery of regulatory milestones, create strategy documents and core labeling,
oversee global dossier construction
- Drive innovative regulatory tools and new ways of working to improve quality and speed
- Collaborate with marketing, regional teams and cross-functional stakeholders to align regulatory views and policy interpretations
- Contribute to non-project initiatives at portfolio or enterprise level
Responsabilidades
- Advanced degree in a science-related field
- Extensive success in cell therapy regulatory strategy
- Deep understanding of global regulatory science and portfolio strategy
- Experience with drug/biologic development processes for complex, first-in-class programs
- Experience in oncology, autoimmune, rare diseases, or neurology therapeutic areas
- Broad pharmaceutical industry experience and regulatory affairs background
- Proven leadership of regulatory and xugodme cross-functional teams in matrix environments
- Strategic, enterprise-level thinking with risk assessment abilities
- Significant experience in health authority interactions in major markets
- Excellent communication, organizational, and presentation skills
- Ability to manage multiple projects in a fast-paced, flexible manner
- Experience with due diligence and business alliances
- Experience in growing teams through coaching or mentoring
- Contribution to external policy, regulatory science, or industry advocacy initiatives
Requisitos principales
- office-based 3 days per week expected
- flexible working arrangements
- inclusive environment with accommodations
- career development and leadership opportunities