Regulatory Affairs Director

Astrazeneca

Job Description 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. Gaithersburg, MD is one of over 400 sites here at AstraZeneca, providing a collaborative and vibrant environment where everyone feels comfortable and able to be themselves is at the core of AstraZeneca’s priorities. 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 Hematology/ Hemato-Oncology 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