Senior Regulatory Affairs Director, Global Regulatory Strategy

Do You Have Expertise in Regulatory Affairs?

Do you have expertise in, and passion for, Regulatory Affairs? Would you like to apply your expertise and channel the scientific capabilities in a company that follows the science and turns ideas into life-changing medicines? Then AstraZeneca might be the one for you!

At AstraZeneca, we are using cell therapy to revolutionize the treatment of life-threatening immune-mediated diseases. We put patients first and strive to meet their unmet needs worldwide. Working here means being entrepreneurial, thinking big, and working together to make the impossible a reality. If you are swift to action, confident to lead, willing to collaborate, and curious about what science can do, then you’re our kind of person.

AstraZeneca’s pipeline of innovative medicines is growing within Immunology Cell Therapy, one of our major therapy areas. To meet the increasing demand for regulatory expertise, we continue to expand our regulatory functions through the recruitment of Regulatory Affairs Strategists (at Director and Senior Director level). You will work across disciplines in an atmosphere of collaboration and inclusion where Regulatory Affairs is a respected voice and considered an equal partner in the business.

The Role: Senior Regulatory Affairs Director

The Senior Regulatory Affairs Director (SRAD), Global Regulatory Strategy, will be responsible for overseeing the development and implementation of global regulatory strategies for assigned products in the Cell Therapy Immunology area, with the intention of achieving successful registration and lifecycle management to serve patient needs.

This individual will, with a high sense of urgency, lead cross-regulatory teams and be accountable to provide key regulatory input to Global Project and Franchise Teams (GPTs/GFTs) deliverables. The individual will also ensure effective communication and constructive working relationships with business partners and representatives of regulatory authorities.

Responsibilities

• Providing regulatory strategic oversight for products and/or projects in the relevant therapeutic areas/portfolio, aligned to overall Enterprise objectives through initial registration and subsequent lifecycle management.
• Lead and support staff in preparation for regulatory authority meetings and provide input to submission strategy and other critical regulatory documents.
• Represent AstraZeneca as the point of contact with relevant Health Authorities and/or lead interactions with such authorities or other relevant external stakeholders.
• Provide input to internal governance and advisory bodies on strategic and procedural/operational issues as they arise.
• Actively collaborate with Senior Management and Enterprise functions (e.g., Clinical, Commercial, Medical Affairs) to provide portfolio or therapeutic-level regulatory insight and broader drug development expertise.
• Stay up-to-date on the latest regulatory requirements and trends.
• Support Business Development activities by conducting Regulatory due diligence, gap assessments, and resource needs evaluation.
• Ensure exemplary behavior, leadership, ethics, and transparency within the Enterprise, with Health Authorities, and other external stakeholders.

Essential Qualifications

• Bachelor’s Degree in a scientific or pharmaceutical discipline.
• 10+ years of regulatory experience in the pharmaceutical industry, with a significant track record in global strategies.
• Strong knowledge of drug development and regulatory policy in immune-mediated diseases or other complex therapy areas, coupled with excellent scientific and business judgment.
• Experience providing strategic regulatory advice for global development in major jurisdictions (e.g., EU, US, China, Japan).
• Successful track record in registering and overseeing regulatory strategies for assets.
• Ability to manage complex issues and coordinate multiple projects simultaneously in a time-sensitive fashion.
• Strong interpersonal and written/verbal communication skills.
• Proven track record practicing sound judgment in risk assessment.
• Highly conversant and knowledgeable about new and emerging regulations and guidances.
• Understanding of GxPs and a solid ability to seek and interpret regulatory information.
• Experience in cell therapy development is a plus.

Why AstraZeneca?

At AstraZeneca, we’re dedicated to being a Great Place to Work. Here, you are empowered to push the boundaries of science and unleash your entrepreneurial spirit. There’s no better place to make a difference to medicine, patients, and society. We champion an inclusive culture, diversity, and collaboration while committing to lifelong learning and development. Join us on this exciting journey to pioneer the future of healthcare.

What’s Next?

Are you ready to bring new ideas and fresh thinking to the table? Brilliant! We have one seat available, and we hope it’s yours.

Commitment to Diversity

AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We welcome and consider applications from all qualified candidates regardless of characteristics. We comply with all applicable laws and regulations on non-discrimination in employment, recruitment, work authorization, and employment eligibility verification requirements.

Learn more here