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

Boston, Massachusetts, United States -

Full Time

Start Date

Immediate

Expiry Date

14 Mar, 26

Salary

317781.0

Posted On

14 Dec, 25

Experience

10 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Regulatory Strategy, Clinical Development, Due Diligence, FDA Guidelines, EMA Guidelines, ICH Guidelines, Biologics, Small Molecules, Cell Therapy, Gene Therapy, Oncology, Portfolio Growth, Innovative Regulatory Approaches, Communication Skills, Team Collaboration, Mentoring

Industry

Pharmaceutical Manufacturing

Description

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 Follow Alexion on LinkedIn Follow AstraZeneca on Facebook Follow AstraZeneca on Instagram Learn more about Alexion at www.alexion.com At Alexion, you will find a collaborative culture that encourages innovation and a diverse environment where your contributions are valued. You will have the opportunity to be at the forefront of rare disease research and make a meaningful difference in patients' lives. Ready to lead and inspire? Apply now and take the first step towards a fulfilling career at Alexion, AstraZeneca Rare Disease. 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. 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. #LI-Hybrid Date Posted 04-Dec-2025 Closing Date 17-Dec-2025 Our mission is to build an inclusive environment where equal employment opportunities are available to all applicants and employees. In furtherance of that mission, we welcome and consider applications from all qualified candidates, regardless of their protected characteristics. If you have a disability or special need that requires accommodation, please complete the corresponding section in the application form. AstraZeneca is a global, science-led, patient-focused biopharmaceutical company. We focus on discovering, developing and commercialising prescription medicines for some of the world’s most serious diseases. But we are more than one of the world’s leading pharmaceutical companies. At AstraZeneca, we’re dedicated to being a Great Place to Work. Where you are empowered to push the boundaries of science, challenge convention and unleash your entrepreneurial spirit. To embrace differences and take bold actions to drive the change needed to meet global healthcare and sustainability challenges. There is no better place to make a difference in medicine, patients, and society. An inclusive culture where you will connect different thinking to generate new and valuable opportunities. Where you will find a commitment to lifelong learning, growth and development for all. Our Inclusion & Diversity (I&D) mission is to create an inclusive and equitable environment where people belong, using the power of our diversity to push the boundaries of science to deliver life-changing medicines to patients. Inclusion and diversity are fundamental to the success of our company, because innovation requires breakthrough ideas that only come from a diverse workforce empowered to challenge conventional thinking. We’re curious about science and the advancement of knowledge. We find creative ways to approach new challenges. We’re driven to make the right choices and be accountable for our actions. As an organisation centred around what makes us human, we put a big focus on people. Across our business, we want colleagues to wake up excited about their day at the office, in the field, or in the lab. Along with our purpose to bring life-changing medicines to people across the globe, we have a promise to you: to help you realise the full breadth of your potential. Here, you’ll do work that has the potential to change your life and improve countless others. And, together with your team, you’ll shape a culture that unites and inspires us every day. This is your life at AstraZeneca.

Responsibilities

The Senior Director will lead regulatory strategy for early-stage programs and conduct regulatory due diligence for business development opportunities. This role involves providing expert guidance to cross-functional teams and ensuring alignment with global health authority expectations.