Regulatory Affairs Director, Oncology

3 weeks ago

Gaithersburg MD, United States AstraZeneca Full time

Would you like to apply your Regulatory Affairs strategy expertise and passion to make an impact in a company that follows the science and turns ideas into life changing medicines?At AstraZeneca, we do this with the upmost integrity even in the most sophisticated situations because we are committed to doing the right thing We continuously forge partnerships that help bring world-class treatments to patients in new ways, combining our people’s outstanding skills with those of people from all over the globe. Within Oncology Regulatory Science Strategy and Excellence (ORSSE), we bring hope and solutions to patients with unmet needs. We work across our ground-breaking pipeline and the business to get medicines to patients as efficiently and optimally as possible.The Regulatory Affairs Director (RAD) provides strategic and operational regulatory leadership to the development, commercialization and life cycle management of assigned oncology products. Serves as the global regulatory lead (GRL) on early stage projects or specific indications of larger programs and/or as the regional regulatory lead. The RAD plays a substantial role crafting and implementing the clinical strategy and influencing health authorities to improve outcomes.What you'll do:Lead cross functional teams in major regulatory submissions (NDA/BLA/IND/CTA), health authority interactions, label discussions, and securing approvals.Develop and implement the program's regional or global strategy ensuring that it is crafted to deliver rapid approval with competitive labeling that is identified by the business, markets and patients.Craft the health authority engagement strategy and interaction plan, drive the formulation of the briefing document focused on strategy and scientific content, lead the team through meeting rehearsals and moderate the meeting itself.Lead a Global Regulatory Strategy Team (GRST) of key contributing members from the regions, emerging markets, RA CMC, Labeling and members of the submission and execution team. Mentor and provide performance feedback to members of your GRST.Deliver regulatory milestones on your team including an assessment of risks and mitigations, emerging data, and the probability of success. Lead preparation of the regulatory strategy document and target product labeling.Own the negotiations with health authorities and initiate and deliver key regulatory documents.Plan and construct the global dossier and core prescribing information including product maintenance, supply and compliance activities.Partner with marketing companies (countries) and regional regulatory affairs staff to influence developing views/guidance.Minimum Qualifications:Bachelor's degree in a science related field with at least 3 years of Regulatory strategy or related knowledge/experience.A solid knowledge of regulatory affairs within at least one therapeutic area in both early and late development.Previous demonstrated experience of regulatory drug development or equivalent, and experience with major HA interactions.Demonstrated competencies of strategic thinking, strategic influencing, risk evaluation, innovation, initiative, leadership and excellent oral and written communication skills.Preferred Qualifications:Advanced degree preferred.Experience in Oncology (small molecules & biologics) is preferred.Prior experience with phase 3 design including end of phase 2 health authority interactions.Contribution to a regulatory approval including leading response team and labeling negotiations.Knowledge and understanding of guiding principles in drug development such as benefit/risk profile, dose selection or statistical design.Broad background of experience working in pharmaceutical business and prior experience in several areas within regulatory affairs.Ability to work strategically within a business critical and high-profile development program.Critical thinking on current global regulatory science questions and good understanding of the corresponding scientific and clinical component.Why AstraZeneca?At AstraZeneca when we see an opportunity for change, we seize it and make it happen, because any opportunity no matter how small, can be the start of something big. Delivering life-changing medicines is about being entrepreneurial - finding those moments and recognising their potential. Join us on our journey of building a new kind of organization to reset expectations of what a bio-pharmaceutical company can be. This means we’re opening new ways to work, pioneering ground-breaking methods and bringing unexpected teams together. Interested? Come and join our journey.So, what’s nextAre you already imagining yourself joining our team? Good, because we can’t wait to hear from you.Where can I find out more?Our Social Media, Follow AstraZeneca on LinkedIn Follow AstraZeneca on Facebook Follow AstraZeneca on Instagram Date Posted07-May-2024Closing Date06-Jun-2024Our mission is to build an inclusive and equitable environment. We want people to feel they belong at AstraZeneca and Alexion, starting with our recruitment process. We welcome and consider applications from all qualified candidates, regardless of characteristics. We offer reasonable adjustments/accommodations to help all candidates to perform at their best. If you have a need for any adjustments/accommodations, please complete the section in the application form.AstraZeneca requires all US employees to be fully vaccinated for COVID-19 but will consider requests for reasonable accommodations as required by applicable law.SummaryLocation: US - Gaithersburg - MD; US - Waltham - MAType: Full time

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