Global Oncology Pediatric Regulatory Strategist (Senior Regulatory Affairs Director) at AstraZeneca in Gaithersburg, Maryland

Job Description:

The Senior Regulatory Affairs Director (SRAD) responsible for oncology paediatric regulatory strategy (OPRS) serves as the regulatory representative on the AZ Paediatric Oncology Development Team (PODT) developing global paediatric strategies and studies across the entire oncology portfolio. In this the SRAD OPS works closely with the GRL and GRST to ensure alignment with the overall program development plan. The SRAD OPRS establishes external relationships with key stakeholders, leveraging these to maintain competitive advantage. You will be viewed as a senior leader within the Regulatory community.



What you'll do

• Work across multiple Global Product Teams (GPTs) in Early Onc, Late Onc and Haematology to support development of paediatric strategies and design of paediatric studies within the AZ PODT operating model


• Develop paediatric regulatory strategies and PIPs/iPSPs working in partnership with the GRL and other GRST members (including reg CMC) to ensure alignment with the overall program development plan.


• Foster knowledge sharing on paediatric topics across the organisation


• Ensure that the strategy is crafted to deliver approval with competitive labelling in keeping with the properties of the product(s) and the needs identified by the business, markets and patients.


• Lead the assessment of emerging paediatric data against aspirations and update ORSSE Leadership on project risks/mitigation activities.


• Represent Regulatory Affairs on Global Product Teams (GPTs) when required providing strategic advice and accountable for all regulatory activities relating to paediatric development.


• Participate in due diligence activities for assets where clinical target indications are paediatric tumors


• Own the delivery of all milestones relating to PIPs/iPSPs including assessment of the probability of regulatory success based on a detailed assessment of risks and mitigations.


• Demonstrate strategic leadership skills thereby contributing to effective product development.


• Partner and influence developing views/guidance relating to paediatric oncology development on a global scale.

Education, Qualifications, Skills and Experience:




Essential:

• An advanced degree in a science related field and/or other appropriate knowledge/experience.


• Experience of developing paediatric strategies including PIPs/iPSPs


• Previous demonstrated experience of regulatory drug development including product approval/launch. Successful leadership to at least one major regulatory approval at a global level including leading response team and labeling negotiations is desired.


• Previous experience in leading major health authority interactions.


• Solid knowledge of regulatory affairs within several therapeutic areas in early and late development.


• 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 leadership experience.


• Ability to think strategically and critically and evaluate risks to regulatory activities.


• Deep understanding of global regulatory science and will integrate with project strategy. You have a long standing experience of overall drug/biologic development processes and strategies for high profile, complex or novel development programs.

Desirable:

• Experience of working on oncology drug development programs


• Experience of working at a regulatory authority involved in discussions around paediatric development


• Previous experience with FDA advisory committee and EMA oral explanation would be a plus


• Previous experience working on due diligence activities and in a business alliance environment.


• Ability to work strategically within a complex, business critical and high-profile development program.

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 $207,658 to $311,488. 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.


Why AstraZeneca?


At AstraZeneca we're dedicated to being a Great Place to Work. Where 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. An inclusive culture that champions diversity and collaboration, and always committed to lifelong learning, growth and development. We're on an exciting journey to pioneer the future of healthcare.


So, 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.


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 believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements. Apply Now