Director, Regulatory Affairs, Regulatory Science & Execution
Director, Regulatory Affairs, Regulatory Science & Execution
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Job Description
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 were 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 Youll 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 Youll 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 -person working gives us the platform to connect work at pace and challenge perceptions. Thats why we work on average a minimum of three days per week from the office. But that doesnt mean were 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 $173600.80 - $260401.20. 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 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-2025Closing Date
11-Oct-2025Our mission is to build an inclusive environment where equal employment opportunities are available to all applicants and 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.
Required Experience:
Director
Employment Type
Full-Time
