Regulatory Affairs Director – Oncology Cell and Gene Therapy
AstraZeneca
Gaithersburg, MD
Permanent
Full-time
25 days ago
AstraZeneca is a global, science-led, patient-focused biopharmaceutical company that focuses on the discovery, development and commercialization of prescription medicines for some of the world’s most serious disease. AstraZeneca’s pipeline of industry-leading innovative medicines is consistently growing, and we are investing in our capabilities to become leaders in the delivery of next-generation cell and gene therapies. At AstraZeneca, 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.Oncology Regulatory Science and StrategyWe are recruiting Regulatory Affairs professionals to join the Oncology Regulatory Science and Strategy (ORSS) team. As Regulatory professionals working on Oncology products, we take innovative regulatory approaches to get medicines to patients as efficiently and effectively as possible.The Regulatory Affairs Director (RAD), Oncology Cell and Gene Therapy provides strategic regulatory leadership to influence the development of our innovative products across all stages of development. The RAD plays a substantial role defining and implementing the regulatory strategy and engages with health authorities to effectively inform our development programs. RADs that work on cell therapy products will have an understanding of the unique pre-clinical, CMC and clinical aspects of cell therapy but depending on the interest of the individual and needs of the portfolio, may also support oncology products outside of cell therapy. This position may serve as the global regulatory lead (GRL) on early stage projects or specific indications of larger programs and/or as the regional regulatory lead.Main Duties and Responsibilities: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 labelling 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.When serving in the role of GRL, lead a Global Regulatory Strategy Team (GRST) of key contributing members from the regions, emerging markets, RA CMC, Labelling 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 labelling.Own the negotiations with health authorities and initiate and deliver key regulatory documents.Play a critical role in Marketing Applications, including driving regional or global strategy for the dossier and core prescribing information and leading the team through response to Health Authority questions during review of the application.Partner with marketing companies (countries) and regional regulatory affairs staff to influence developing views/guidance.Minimum Qualifications:A Bachelor's degree in a science related field and/or other appropriate knowledge/experience. Total of 6 years of relevant experience, which may include education and training positions.A solid knowledge of regulatory affairs, including proven track record of regulatory drug development and experience with major HA interactions.Demonstrated experience in global IND/CTA filings and support for CGT/ATMP products.Demonstrated competencies of strategic thinking, strategic influencing, risk evaluation, innovation, initiative, leadership and excellent oral and written communication skills.The ability to think strategically and critically and evaluate risks to regulatory activities.Desirable Qualifications:While not required, experience in Oncology drug development is importantPrior experience with phase 3 design including end of phase 2 health authority interactionsContribution to a regulatory approval including leading response team and labelling negotiationsKnowledge and understanding of guiding principles in drug development such as benefit/risk profile, dose selection or statistical designBroad background of experience working in pharmaceutical business and prior experience in several areas within regulatory affairsAbility to work strategically within a business critical and high-profile development programCritical 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 next!Are 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 LinkedInFollow AstraZeneca on FacebookFollow AstraZeneca on InstagramDate Posted 02-Apr-2024Closing Date 01-May-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.
