Astrazeneca
RegulatoryAffairsGroupDirector,LateCVRMRegulatoryAffairs
“Regulatory Affairs Group Director, Late CVRM Regulatory Affairs at Astrazeneca. Skills: Regulatory Affairs, Drug Development, Leadership. Line management of 7-12 regulatory professional staff. Contribute to the strategy, direction and efficient operation of the Regulatory TA organization as well as the RAM community”
What You'll Achieve.
Ensure high quality drug project operational delivery and efficiency by the group
What They're Looking For.
Must Have
University Degree in Science or a related subject area, Extensive regulatory affairs and drug development experience within the biopharmaceutical industry, or at a health authority, Knowledge of regulatory requirements, procedures and legislation for drug development, throughout the product lifecycle, Proven successful leadership and project management experience, Excellent collaboration, teamwork, oral and written communication skills, influencing and negotiating skills.
Nice to Have
experience of leading major first wave submissions, leading complex regulatory procedures across projects/products, experience of developing teams
What You'll Do.
Line management of 7-12 regulatory professional staff
Contribute to the strategy
direction and efficient operation of the Regulatory TA organization as well as the RAM community
Provide regulatory expertise and oversight to ensure high quality drug project operational delivery and efficiency by the group
Work on a drug project in a RAM role or drive continuous improvement or change projects
coaching and line management for a group of Regulatory Affairs Managers
targeted recruitment for the group
Lead talent and performance development activities
Collaborate with the RAM leadership team to set the strategy for tactical delivery and efficiency for drug projects
Lead development and continuous improvement of expert and/or process area and/or work on a drug project
Establish and develop relationships with key partners
internally and externally
How You'll Work.
Team & Collaboration
Crafting a collaborative culture that champions knowledge-sharing; Work across teams, functions and even the globe; Engaging face-to-face in our offices 3 days a week; Collaborate with the RAM leadership team; Establish and develop relationships with key partners, internally and externally; Excellent collaboration, teamwork skills
Communication Scope
Excellent oral and written communication skills
Process & Methodology
Proven successful project management experience, Drive continuous improvement or change projects, Lead development and continuous improvement of expert and/or process area and/or work on a drug project
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