AstraZeneca · 2 months ago
Senior Director, Global Regulatory Strategy - Early Development & Business Development
US - Boston - MA
Full-time
Hybrid
Director/Executive
$212K/yr - $318K/yr
10+ years expAstraZeneca is a leading biopharmaceutical company dedicated to innovation and collaboration. The Senior Director, Global Regulatory Strategy will spearhead regulatory strategy for early-stage programs and lead regulatory due diligence for business development opportunities, ensuring clinical development plans align with global health authority expectations.
BiotechnologyMedical DeviceHealthcarePharmaceuticalBiopharmaHealth CareMedicalPrecision Medicine
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
Qualification
Required
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
Preferred
Multi-regional experience (US, EU, Japan, Emerging Markets)
Prior experience in rare disease, oncology, or cell and gene therapy
Benefits
Eligibility for various incentives—an opportunity to receive short-term incentive bonuses, equity-based awards for salaried roles and commissions for sales roles
Qualified retirement programs
Paid time off (i.e., vacation, holiday, and leaves)
Health, dental, and vision coverage in accordance with the terms of the applicable plans
Company
AstraZeneca
AstraZeneca is a pharmaceutical company that discovers, develops, manufactures, and markets prescription medicines. It is a sub-organization of Investor.
10001+ employees
Funding
Current Stage
Public CompanyTotal Funding
$5.26B2024-07-30Post Ipo Debt· $1.51B
2023-02-28Post Ipo Debt· $2.25B
2023-02-24Post Ipo Debt· $1.5B
Leadership Team
Pascal Soriot
Executive Director and Chief Executive Officer
Aradhana Sarin
Group CFO and Executive Director
Recent News
Portugal News
2026-02-09
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2026-02-07
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2026-02-07
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