Executive Director, Regulatory Affairs Strategy - Cell Therapy

About the Company

Requirements

• ● Bachelor degree in a science-related field and at least ten or more years of experience and/or appropriate knowledge/experience.
• ● Demonstrated extensive success in cell therapy regulatory strategy.
• ● Deep understanding of global regulatory science and integration with program, franchise, and portfolio strategy.
• ● Long-standing experience of overall drug/biologic development processes and strategies for high profile, highly complex, novel, or first-in-class development programs.
• ● Broad background of experience working in the pharmaceutical business and prior experience in several areas within regulatory affairs.
• ● Proven experience leading regulatory and cross-functional teams, influencing senior stakeholders, and operating effectively in complex matrix environments.
• ● Ability to think strategically and critically at enterprise level and evaluate risks to regulatory and business activities.
• ● Previous significant experience in leading Health Authority interaction in major markets. 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.
• ● Master's Degree, PhD or MD in a science related field.
• ● 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 we need 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.
• ● 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 in for this position in the US, ranges from 276,000 - 414,000. 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.
• ● Join us in our unique and ambitious world.
• ● Why AstraZeneca: Here, transformative science meets decisive execution. You will help convert cutting-edge cell therapy innovation into globally approved medicines for patients with unmet needs, working in a connected, inclusive environment that values kindness alongside ambition.
• ● We bring diverse experts together to spark bold ideas, apply modern regulatory approaches, and harness data and technology to shorten development cycles. With a rich pipeline and empowered teams, your leadership will shape labels, accelerate access, and create lasting impact for patients worldwide.