Senior Regulatory Affairs Director

Senior Regulatory Affairs Director - Oncology

Are you a seasoned regulatory affairs professional with a passion for oncology and a drive to make a tangible impact on patients' lives? AstraZeneca, a global leader in pharmaceutical innovation, is seeking a highly strategic and experienced Senior Regulatory Affairs Director to join our dynamic R&D Oncology team. This is an exceptional opportunity to lead the charge in bringing groundbreaking therapies from late-stage development to patients worldwide.

What Makes This Opportunity Stand Out?

At AstraZeneca, we are united by a shared commitment to integrity and a relentless pursuit of scientific excellence. As a Senior Regulatory Affairs Director, you will be at the forefront of our mission, channeling your expertise to transform innovative science into vital new medicines. This role offers:

• Strategic Leadership in a High-Impact Area: You will be accountable for defining and executing the global regulatory strategy for complex and high-profile oncology products. This involves not just navigating regulatory landscapes but actively shaping them to ensure rapid approvals and advantageous labeling that reflect the true value of our therapies.
• Pivotal Role in Drug Development: You will be instrumental in the late-stage development of our innovative oncology pipeline, bridging the gap between exciting science and accessible, life-changing medicines. Your work will directly contribute to the availability of novel treatments for patients facing challenging diseases.
• Global Impact and Collaboration: This position demands a deep understanding of global regulatory science and drug development processes. You will lead a Global Regulatory Sub-team (GRST), fostering collaboration with regional experts, emerging markets, CMC, and delivery teams, ensuring a cohesive and effective global regulatory approach.
• End-to-End Product Responsibility: Your remit extends beyond initial approvals to encompass product maintenance, supply, and ongoing compliance activities for marketed oncology brands, ensuring continued patient access and safety.
• Development and Mentorship: You will lead and develop a team of regulatory professionals, providing crucial leadership, coaching, and performance feedback. This is an opportunity to shape the next generation of regulatory leaders within AstraZeneca.
• Flexible Work Environment: AstraZeneca recognizes the importance of work-life balance. Our "ways of working" allow for a blend of personal and professional commitments, with a collaborative office presence three days a week, fostering both teamwork and individual flexibility.

Key Considerations for Your Career Path:

This role is ideal for a candidate who thrives in a complex and high-stakes environment and possesses a strategic mindset. To excel in this position, consider the following:

• Deep Regulatory Expertise: A strong foundation in regulatory affairs, particularly within one or more oncology therapeutic areas, is essential. Your expert knowledge will be critical in guiding product development and interactions with health authorities.
• Proven Leadership in Major Interactions: Significant experience leading interactions with major health authorities is a must. Your ability to effectively communicate and negotiate will be paramount.
• Strategic Risk Management: The capacity to conduct robust regulatory risk planning and mitigation is crucial. You will be responsible for assessing probabilities of success and developing strategies to overcome potential challenges.
• Scientific and Clinical Acumen: A solid scientific and clinical understanding of regulatory sciences, combined with experience in both small molecules and biologics within the relevant therapy area, will be highly advantageous.
• Global Perspective: This role requires a broad background in the pharmaceutical business and prior experience across various regulatory affairs functions. A proven track record of contributing to major global regulatory approvals is a strong indicator of success.
• Strategic Thinking and Influence: The ability to think strategically, critically evaluate risks, and influence developing views and guidance within the organization and with external stakeholders is a core competency.

If you are a visionary leader ready to make a significant contribution to the fight against cancer and are seeking a role that offers both intellectual challenge and profound impact, this Senior Regulatory Affairs Director position at AstraZeneca could be the perfect next step in your career journey.