Senior Regulatory Affairs Director - Oncology Cell & Gene Therapy

About the Company

Requirements

• ● An advanced degree in a science related field and seven-ten years of experience and/or appropriate knowledge/experience.
• ● Demonstrated success in cell and/or gene therapy regulatory strategy.
• ● Deep understanding of global regulatory science and integration with program strategy. Long standing experience of overall drug/biologic development processes and strategies for high profile, complex or novel development programs.
• ● Broad background of experience working in pharmaceutical business and prior experience in several areas within regulatory affairs. Experience in Oncology (small molecules & biologics) is preferred.
• ● Proven experience leading regulatory and cross-functional teams, and stakeholder management.
• ● Ability to think strategically and critically and evaluate risks to regulatory activities.
• ● Previous experience in leading major Health Authority interactions.
• ● Excellent oral, written, and presentation skills.
• ● Strong organizational skills.
• ● Ability to work in a fast-paced environment in a hands-on fashion.
• ● Flexible and proactive, with the ability to manage multiple projects and successfully adapt to changing business needs and priorities.
• ● Successful leadership of at least one global regulatory approval including leading response team and labeling negotiations
• ● Contribution to non-project business initiatives (e.g. at a portfolio or cross functional level)
• ● At AstraZeneca, Regulatory professionals help turn breakthrough science into real solutions for patients with serious diseases by shaping innovative pathways through complex global requirements. Working with colleagues across locations, therapy areas and external partners, this role offers the chance to influence strategy end-to-end, from early development through rapid global approvals, while learning from leading experts, sharing best practices and using data, technology and modern approaches to reduce barriers for patients worldwide.
• ● If this opportunity to drive transformative cell and gene therapies towards approval resonates, apply now to join us in bringing life-changing medicines to those who need them most.
• ● Competitive salary and benefits package on offer:
• ● 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.
• ● The annual base salary for this position ranges from 218,058.40 - 327,087.60. However, 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) or to receive a retirement contribution (hourly 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 salary (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 26-Aug-2026
• ● Closing Date 09-Sept-2026 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.