Alexion Pharmaceuticals
Director, Regulatory Affairs, Regulatory Science & Execution
Alexion Pharmaceuticals, Boston, Massachusetts, us, 02298
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. We offer 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. Alexion is an equal opportunities employer. 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 contact us.
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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. We offer 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. Alexion is an equal opportunities employer. 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 contact us.
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