Senior Director, Global Regulatory Strategy - Early Development & Business Development

Senior Director, Global Regulatory Strategy - Early Development & Business Development

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Job Title :

Senior Director, Global Regulatory Strategy - Early Development & Business Development

Location : Boston, MA

At AstraZeneca, we pride ourselves on crafting a collaborative culture that champions knowledge-sharing, ambitious thinking and innovation – ultimately providing employees with the opportunity to work across teams, functions and even the globe. Recognizing the importance of individualized flexibility, our ways of working allow employees to balance personal and work commitments while ensuring we continue to create a strong culture of collaboration and teamwork by engaging face‑to‑face in our offices

3 days a week . Our head office is purposely designed with collaboration in mind, providing space where teams can come together to strategize, brainstorm and connect on key projects. As AstraZeneca continues to put patients at the forefront of our mission, we are excited for our move to Kendall Square / Cambridge in 2026. Find out more information here : Kendall Square Press Release. At Alexion, Rare Disease everything we do is underpinned by our dedication to being a Great Place to Work. Put simply, our people are our greatest asset. We know that with a talented, brave and diverse team that believes in making a meaningful impact for people living with rare diseases, every day – incredible things happen. Joining Alexion means embracing an opportunity where work isn’t ordinary, in a company where 'Here it means more' is more than a statement, it’s an ethos. We are a beacon in the global BioPharmaceutical landscape. Our closeness to patients brings us closer to our work and closer to each other. Combined with our brave, pioneering spirit – we are truly unique in R&D and healthcare. At Alexion, grow and innovate in a business with a rapidly expanding portfolio. Enjoy the vibe, entrepreneurial spirit and autonomy of a leading biotech. You’ll join an energising and kind culture where people build connections to explore new ideas and learn. As an important member of our commercial team, you'll be meeting the needs of some of the most underserved patients in the world.

Introduction To Role

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.

Accountabilities

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.

Essential Skills / Experience

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.

Desirable Skills / Experience

Multi-regional experience (US, EU, Japan, Emerging Markets)

Prior experience in rare disease, oncology, or cell and gene therapy.

Where can I find out more?

Follow AstraZeneca on LinkedIn

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Learn more about Alexion at www.alexion.com

Total Rewards

The annual base pay (or hourly rate of compensation) for this position ranges from $211,854.40 to $317,781.60. Our positions offer eligibility for various incentives—an opportunity to receive short‑term incentive bonuses, equity‑based awards for salaried roles and commissions for sales roles. 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.

Equal Employment Opportunity Statement

Alexion embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry‑leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non‑discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements. Alexion is committed to accommodating persons with disabilities. Such accommodation is available on request in respect of all aspects of the recruitment, assessment and selection process and may be requested by emailing AZCHumanResources@astrazeneca.com.

Date Posted : 19-Nov-2025

Closing Date : 02-Dec-2025

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