Alexion
Director, Regulatory Affairs, Regulatory Science & Execution
Alexion, Boston, Massachusetts, us, 02298
Overview
Lead the Future of Regulatory Strategy for Rare Diseases. Are you a strategic regulatory leader ready to shape the development and lifecycle of innovative therapies for rare and serious diseases? Do you thrive in fast-paced, high-impact environments where science, strategy, and global health intersect? At
Alexion, AstraZeneca Rare Disease , we’re seeking a
Director of Regulatory Affairs – Strategy & Execution
to drive the regulatory vision and execution for our most complex and groundbreaking therapies. This is your chance to
make an impact at the intersection of cutting-edge science and global health
and help patients with urgent unmet medical needs around the world. What You’ll Do
Own and drive regulatory strategy Serve as the
Regulatory Lead
for one or more late-stage or marketed products, leading end-to-end regulatory strategy across the US and/or other key global jurisdictions (EU, UK, Canada). Design and implement submission strategies to support product development, registration, and lifecycle management; including
INDs, CTAs, BLAs/NDAs, Orphan Drug Designation, pediatric plans , and more. Be the voice of regulatory leadership Lead interactions and meetings with major
Health Authorities
(FDA, EMA, HC, MHRA), representing Alexion with confidence and credibility. Act as a strategic partner to Clinical, Medical Affairs, Commercial, and Global Program Teams, providing regulatory input that shapes development plans and product strategy. Lead execution of key submissions Oversee regulatory documentation, timelines, and team deliverables with precision — ensuring timely and high-quality submissions aligned with regional and global objectives. Collaborate cross-functionally with Regulatory Operations, Labeling, and CMC to ensure alignment and success. Shape the future of regulatory science Stay on the pulse of emerging regulatory trends, guidances, and policy shifts. Use your insight to
advocate for regulatory innovation
and influence internal and external strategy. Support enterprise-level regulatory process development, audit readiness, and inspection response. Inspire, mentor, and lead Provide
strategic and tactical mentorship
to regulatory colleagues and cross-functional team members. Contribute to team culture by role-modeling transparency, ethics, and regulatory excellence. What You’ll Bring
8+ years
of experience in Regulatory Affairs within pharma or biotech, including
US regulatory strategy and submissions . Proven leadership in global regulatory strategy across the drug development lifecycle, from early development through marketing applications and post-market support. Deep understanding of the
drug development process , global regulatory frameworks, and
rare disease or specialty drug
pathways. Track record of
leading meetings with Health Authorities
and managing complex regulatory submissions. Strong working knowledge of
GxPs, emerging regulations , and regulatory intelligence tools. Demonstrated ability to think strategically, manage risk, and make sound regulatory judgments in fast-moving environments. Exceptional collaboration and communication skills — able to influence at all levels, including senior leadership. When we put unexpected teams in the same room, we unleash bold thinking with the power to inspire life-changing medicines. In-person working gives us the platform to connect, work at pace and challenge perceptions. That’s why we work, on average, a minimum of three days per week from the office. But that doesn’t mean we’re not flexible. We balance the expectation of being in the office while respecting individual flexibility. Join us in our unique and ambitious world. 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. #LI-Hybrid The annual base pay for this position ranges from $173,600.80 - $260,401.20. Hourly and salaried non-exempt employees will also be paid overtime pay when working qualifying overtime hours. Base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience. In addition, our positions offer a short-term incentive bonus opportunity; eligibility to participate in our equity-based long-term incentive program. Benefits offered included a qualified retirement program [401(k) plan]; paid vacation and holidays; paid leaves; and, health benefits including medical, prescription drug, dental, and vision coverage in accordance with the terms and conditions of the applicable plans. Additional details of participation in these benefit plans will be provided if an employee receives an offer of employment. If hired, employee will be in an “at-will position” and the Company reserves the right to modify base pay (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department/team performance, and market factors. Date Posted: 01-Oct-2025 Closing Date : 11-Oct-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.
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Lead the Future of Regulatory Strategy for Rare Diseases. Are you a strategic regulatory leader ready to shape the development and lifecycle of innovative therapies for rare and serious diseases? Do you thrive in fast-paced, high-impact environments where science, strategy, and global health intersect? At
Alexion, AstraZeneca Rare Disease , we’re seeking a
Director of Regulatory Affairs – Strategy & Execution
to drive the regulatory vision and execution for our most complex and groundbreaking therapies. This is your chance to
make an impact at the intersection of cutting-edge science and global health
and help patients with urgent unmet medical needs around the world. What You’ll Do
Own and drive regulatory strategy Serve as the
Regulatory Lead
for one or more late-stage or marketed products, leading end-to-end regulatory strategy across the US and/or other key global jurisdictions (EU, UK, Canada). Design and implement submission strategies to support product development, registration, and lifecycle management; including
INDs, CTAs, BLAs/NDAs, Orphan Drug Designation, pediatric plans , and more. Be the voice of regulatory leadership Lead interactions and meetings with major
Health Authorities
(FDA, EMA, HC, MHRA), representing Alexion with confidence and credibility. Act as a strategic partner to Clinical, Medical Affairs, Commercial, and Global Program Teams, providing regulatory input that shapes development plans and product strategy. Lead execution of key submissions Oversee regulatory documentation, timelines, and team deliverables with precision — ensuring timely and high-quality submissions aligned with regional and global objectives. Collaborate cross-functionally with Regulatory Operations, Labeling, and CMC to ensure alignment and success. Shape the future of regulatory science Stay on the pulse of emerging regulatory trends, guidances, and policy shifts. Use your insight to
advocate for regulatory innovation
and influence internal and external strategy. Support enterprise-level regulatory process development, audit readiness, and inspection response. Inspire, mentor, and lead Provide
strategic and tactical mentorship
to regulatory colleagues and cross-functional team members. Contribute to team culture by role-modeling transparency, ethics, and regulatory excellence. What You’ll Bring
8+ years
of experience in Regulatory Affairs within pharma or biotech, including
US regulatory strategy and submissions . Proven leadership in global regulatory strategy across the drug development lifecycle, from early development through marketing applications and post-market support. Deep understanding of the
drug development process , global regulatory frameworks, and
rare disease or specialty drug
pathways. Track record of
leading meetings with Health Authorities
and managing complex regulatory submissions. Strong working knowledge of
GxPs, emerging regulations , and regulatory intelligence tools. Demonstrated ability to think strategically, manage risk, and make sound regulatory judgments in fast-moving environments. Exceptional collaboration and communication skills — able to influence at all levels, including senior leadership. When we put unexpected teams in the same room, we unleash bold thinking with the power to inspire life-changing medicines. In-person working gives us the platform to connect, work at pace and challenge perceptions. That’s why we work, on average, a minimum of three days per week from the office. But that doesn’t mean we’re not flexible. We balance the expectation of being in the office while respecting individual flexibility. Join us in our unique and ambitious world. 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. #LI-Hybrid The annual base pay for this position ranges from $173,600.80 - $260,401.20. Hourly and salaried non-exempt employees will also be paid overtime pay when working qualifying overtime hours. Base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience. In addition, our positions offer a short-term incentive bonus opportunity; eligibility to participate in our equity-based long-term incentive program. Benefits offered included a qualified retirement program [401(k) plan]; paid vacation and holidays; paid leaves; and, health benefits including medical, prescription drug, dental, and vision coverage in accordance with the terms and conditions of the applicable plans. Additional details of participation in these benefit plans will be provided if an employee receives an offer of employment. If hired, employee will be in an “at-will position” and the Company reserves the right to modify base pay (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department/team performance, and market factors. Date Posted: 01-Oct-2025 Closing Date : 11-Oct-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.
#J-18808-Ljbffr