Head of Regulatory Affairs, Cell Therapy Immunology

Welcome to AstraZeneca's innovative team, where we are dedicated to transforming the lives of patients through groundbreaking cell therapy and immunology treatments. We are seeking a highly experienced and dynamic individual to join us as our Head of Regulatory Affairs for Cell Therapy Immunology. In this role, you will play a crucial role in shaping the regulatory strategy of our cell therapy and immunology portfolio, ensuring compliance with global regulations and driving the successful approval and launch of new treatments. If you have a strong background in regulatory affairs, a deep understanding of cell therapy and immunology, and a passion for making a difference in patients' lives, we encourage you to read on and apply for this exciting opportunity.

1. Develop and implement regulatory strategies for AstraZeneca's cell therapy and immunology portfolio in alignment with global regulations and company objectives.
2. Serve as the primary point of contact for all regulatory interactions with health authorities, including preparing and submitting regulatory submissions.
3. Stay up-to-date on changes in regulatory requirements and communicate potential impacts to relevant teams.
4. Collaborate with cross-functional teams to ensure that all regulatory requirements are met throughout the product development process.
5. Lead and mentor a team of regulatory professionals, providing guidance and support in their professional development.
6. Build and maintain relationships with key stakeholders, including regulatory authorities and external partners.
7. Participate in and provide regulatory guidance for clinical development and commercialization activities.
8. Evaluate and assess the potential regulatory impact of new product development opportunities.
9. Ensure compliance with all relevant regulatory requirements, including monitoring and reporting adverse events and product complaints.
10. Represent AstraZeneca at industry conferences and meetings to stay informed about industry trends and best practices.
11. Prepare and present regulatory updates and progress reports to senior management.
12. Collaborate with cross-functional teams to develop and implement risk management strategies for the cell therapy and immunology portfolio.
13. Continuously assess and improve regulatory processes and procedures to ensure efficiency and compliance.
14. Communicate regulatory requirements and expectations to internal stakeholders and provide guidance on how to meet these requirements.
15. Monitor and track changes in the competitive landscape and regulatory environment to inform business decisions.

According to JobzMall, the average salary range for a Head of Regulatory Affairs, Cell Therapy Immunology in Boston, MA, USA is between $150,000 and $250,000 per year. This can vary depending on the specific company, level of experience, and other factors.

AstraZeneca plc is a British-Swedish multinational pharmaceutical and biopharmaceutical company.