Regulatory Affairs Director - Oncology Cell & Gene Therapy - AstraZeneca, plc : Job Details

Develop and implement regional or global strategy ensuring that it is crafted to deliver efficient action, and, in the case of marketing authorizations, with competitive labelling that is identified by the business, markets and patients. Lead cross functional teams in major regulatory submissions (IND/ CTA/ NDA/ BLA), health authority interactions, responses to queries, label discussions, and securing approvals. 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, you will 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 with your team, including an assessm...Regulatory Affairs, Director, Oncology, Regulatory, Business Services