Director, Global Regulatory Intelligence
hace 1 mes
The Director, Global Regulatory Intelligence is an expert in performing complex queries and providing highly specialized news, analysis and trends to AZ Regulatory teams globally and across all therapeutic areas, thereby enabling the development of regulatory strategies and the shaping of policy positions. Works closely with other Regulatory Intelligence colleagues (for example, TA Regulatory Intelligence Directors) and related groups (for example, Global Insights, Analytics, and Commercial Excellence (GIACE) and Clinical Information Science) to provide a disease area specific Regulatory interpretation and impact analysis of emerging information. Is recognized as an expert in global regulatory intelligence systems and tools, driving a consistent approach to their use and overseeing their maintenance and advancement, in conjunction with IT experts. Through training and onboarding activities, ensures regulatory colleagues globally can make the best use of intelligence tools and information resources. Contributes to the strategy, direction and efficient operation of the group
Typical Accountabilities
The Global Regulatory Intelligence Director:
- Performs bespoke Regulatory queries on behalf of regulatory project teams;
- Conducts Intelligence surveillance of external sources for communication to regulatory project teams, including specific alerts, and newsletter services;
- Maintains an archive of intelligence information for future reference;
- Contributions as required to Disease Area Landscape documents;
- Is recognized as an expert in global regulatory intelligence systems and tools, driving a consistent approach to their use;
- Proactively seeks improvements in Regulatory Intelligence IT systems and tools, including evaluation of new commercial solutions.
- Actively engages with the Regulatory Intelligence and Information System Advisory Board;
- Provides training, best practice knowledge sharing and onboarding activities to ensure regulatory colleagues can make best use of intelligence resources.
- Is a key stakeholder on AZ Library committee which reviews database, journals and other software license terms and renewals;
- Actively engages with relevant intelligence groups across AZ and external to AZ;
- Provides support and cover for colleagues, as needed:
- Scans relevant websites for published calls for comments and final guidance/legislative documents; ensures the calls for comments procedures are followed and contributes to continuous improvement of the process;
- Supports maintenance of the calendar of public meetings and reports on key Health Authority events and publications;
- Has personal responsibility for creating a culture of courageous leadership, creativity and collaboration;
- Contribute to the strategy, direction and efficient operation of the group.
Essential
Education, Qualifications, Skills and Experience
- Experienced Regulatory professional with degree in a science or related discipline;
- Broad global understanding of intelligence and therapeutic functions within Regulatory Affairs;
- Thorough and in-depth knowledge of Regulatory Intelligence and TA Strategy including experience in multiple Therapeutic areas;
- Breadth of knowledge of the theories and practices of general Drug Development, with a specific understanding of AstraZeneca’s Drug Development Planning and Business information flows;
- Experience in project management;
- Excellent written and verbal communication skills;
- Leadership skills.
Desirable
- Significant Regulatory Experience across global projects and regions
- Problem solving skills
- Focus on delivery and results
- Excellent strategic influencing and negotiation
- Develops collaborative working relationships
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