Director, Regulatory Affairs, Regulatory Science & Execution

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.

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 (salaried roles), to receive a retirement contribution (hourly roles), and commission payment eligibility (sales roles). 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

Closing Date

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.