Senior Director, Global Regulatory Strategy - Early Development & Business Development
About The Position
The Senior Director, Global Regulatory Strategy, will spearhead regulatory strategy for early-stage programs and lead regulatory due diligence for business development opportunities. You will integrate robust scientific expertise into regulatory decision-making, ensuring clinical development plans are both scientifically sound and aligned with global health authority expectations. You will shape global regulatory pathway design for novel therapeutics, ensure alignment with Alexion’s portfolio strategy, and provide expert guidance to cross-functional teams. This role requires deep regulatory expertise, strategic vision, and the ability to influence internal and external stakeholders effectively.
Requirements
- Master's degree in a relevant scientific discipline (or equivalent knowledge/experience).
- 10+ years of pharmaceutical industry experience in global regulatory strategy with strong scientific and clinical development expertise.
- Proven ability to evaluate and interpret nonclinical data to build robust IND-enabling packages, and support efficient clinical development strategies across multiple therapeutic areas.
- Previous experience working on due diligence activities and business alliance environments, including integrating new assets and driving portfolio growth.
- Experience providing strategic regulatory advice for the global development of products through all stages of development including pre-approval and marketed assets.
- Comprehensive knowledge of FDA, EMA, and ICH guidelines; experience with various therapeutic modalities (biologics, small molecules, cell/gene therapy).
- Demonstrated ability to innovate, lead change, and solve critical regulatory science questions in a dynamic environment.
- Exceptional written and verbal communication skills with influence across functions and geographies.
- Ability to build relationships and work collaboratively at all levels in a global, matrixed organization.
Nice To Haves
- Multi-regional experience (US, EU, Japan, Emerging Markets)
- Prior experience in rare disease, oncology, or cell and gene therapy.
Responsibilities
- Provide expert regulatory guidance to preclinical and clinical teams, shaping clinical development plans for candidate assets; represent regulatory at governance forums.
- Lead regulatory due diligence assessments for licensing, acquisitions, and partnerships opportunities; evaluate regulatory risks/opportunities and integrate new assets into Alexion’s portfolio.
- Serve as Global Regulatory Lead for assigned assets, including new modalities (cell/gene therapy) or rare oncology programs. May act as the primary liaison with FDA, EMA, and other global agencies and lead critical interactions (pre-IND, Scientific Advice).
- Partner with R&D, Clinical Development, and Commercial teams to align regulatory strategy with business objectives and portfolio priorities.
- Champion innovative regulatory approaches (e.g., expedited pathways, novel trial designs, real-world evidence) while ensuring the highest standards of GxP compliance.
- Build regulatory team capabilities in due diligence and business development by providing hands-on coaching and mentoring.
Benefits
- Benefits offered include qualified retirement programs, paid time off (i.e., vacation, holiday, and leaves), as well as health, dental, and vision coverage in accordance with the terms of the applicable plans.
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What This Job Offers
Job Type
Full-time
Career Level
Director
Number of Employees
5,001-10,000 employees
